RAMIPRIL 2.5 mg Coated tablets

Зміст інструкції

1. RAMIPRIL ALMUS 2.5 mg, 5 mg or 10 mg tablets
   1. What is RAMIPRIL ALMUS and what it is used for
   2. What you need to know before taking RAMIPRIL ALMUS
   3. How to take RAMIPRIL ALMUS
   4. Possible side effects
   5. How to store RAMIPRIL ALMUS
   6. Package Contents and Other Information

RAMIPRIL ALMUS 2.5 mg, 5 mg or 10 mg tablets

Generic Medicine
Read this leaflet carefully before taking 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 for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is RAMIPRIL ALMUS and what it is used for

RAMIPRIL ALMUS contains a medicine called ramipril which belongs to the group of medicines called
ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).
RAMIPRIL ALMUS works by:
Decreasing the production, by the body, of substances that can cause an increase in
blood pressure
Relaxing and widening its blood vessels
Making it easier for its heart to pump blood around the body.
RAMIPRIL ALMUS can be used:
To treat high blood pressure (hypertension)
To reduce the risk of a heart attack or stroke
To reduce the risk or delay the worsening of kidney problems (whether or not you have diabetes)
To treat your heart when it cannot pump enough blood around the rest of the body
(heart failure)
As treatment after a heart attack (myocardial infarction) if associated with heart
failure.

2. What you need to know before taking RAMIPRIL ALMUS

Do not take RAMIPRIL ALMUS:
If you are allergic to ramipril, to other ACE-inhibitor medicines or to any of the other components of
this medicine (listed in section 6). Signs of an allergic reaction can include skin rashes, difficulty
swallowing or breathing, swelling of the lips, face, throat or tongue.
If you have had a serious allergic reaction called “angioedema”. The signs include itching, skin
rash (urticaria), red patches on the hands, feet and throat, swelling of the throat and tongue,
swelling around the eyes and lips, difficulty breathing and swallowing.
If you are taking or are also 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).
If you are on dialysis or are undergoing any other type of blood filtration. Depending on the machinery that
is used, RAMIPRIL ALMUS may not be suitable for you.
If you have kidney problems due to insufficient blood supply to the kidney (renal artery stenosis).
During the last 6 months of pregnancy (see below “Pregnancy and breastfeeding”).
If your blood pressure is excessively low or unstable. The 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.
Do not take RAMIPRIL ALMUS if any of the above conditions apply to you. If you are unsure, ask
your doctor before taking RAMIPRIL ALMUS.

Warnings and precautions
Talk to your doctor or pharmacist before taking RAMIPRIL ALMUS:
If you have heart, liver or kidney problems.
If you have lost a lot of salts or body fluids (due to an illness such as vomiting, diarrhea,
excessive sweating, or following a low-salt diet, or after taking diuretics for a
long period of time or having undergone dialysis).
If you are about to undergo treatment to reduce the allergy to bee or wasp stings
(desensitization).
If you are going to receive an anesthetic. This may be given for surgery or dental
treatment. It may be necessary to stop treatment with RAMIPRIL ALMUS the
day before, ask your doctor for advice.
If you have a high amount of potassium in your blood (shown by a blood test).
If you are taking medicines or are in conditions where sodium levels in the blood may
decrease. Your doctor may prescribe blood tests at regular intervals, especially to
check sodium levels in the blood, particularly if you are elderly.
If you are taking any of the following medicines, the risk of angioedema may be increased:
medicines used to prevent organ rejection and to treat cancer (such as temsirolimus,
everolimus, sirolimus), vildagliptin (a medicine used to treat diabetes), racecadotril (a
medicine used to treat diarrhea) or sacubitril/valsartan. For sacubitril/valsartan see paragraph
2 “Do not take RAMIPRIL ALMUS”.
If you have a connective tissue disease such as scleroderma or systemic lupus erythematosus.
You must tell your doctor if you think you may be pregnant (or might become pregnant). RAMIPRIL ALMUS is
not recommended in the first 3 months of pregnancy and can cause serious harm to the baby after 3 months of
pregnancy (see below “Pregnancy and breastfeeding”);
If you are taking one of the following medicines used to treat high blood pressure:

• an “angiotensin II receptor antagonist” (AIIRA) (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 the amount of electrolytes (e.g. potassium) in
your blood at regular intervals. See also what is reported in the section "Do not take
RAMIPRIL ALMUS".

Children and adolescents
The use of RAMIPRIL ALMUS is not recommended in children and adolescents under 18 years of age
because the safety and efficacy of RAMIPRIL ALMUS in children have not yet been established .
If any of the conditions described above occur (or you are unsure), ask your doctor before taking
RAMIPRIL ALMUS.

Other medicines and RAMIPRIL ALMUS
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines. This is because RAMIPRIL ALMUS can affect the mechanism of action of some other
medicines. Also, some medicines can affect the mechanism of action of RAMIPRIL ALMUS.
Tell your doctor if you are taking any of the following medicines. These medicines may interfere with
RAMIPRIL ALMUS by altering its action:
Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indomethacin, aspirin).
Medicines used to treat low blood pressure, shock, heart failure, asthma or allergies such as ephedrine, norepinephrine 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, when taken with RAMIPRIL
ALMUS, may increase the likelihood of side effects:
Sacubitril/valsartan - used to treat a type of long-term (chronic) heart failure
in adults (see paragraph 2 “Do not take RAMIPRIL ALMUS”).
Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indomethacin, aspirin).
Cancer medicines (chemotherapy).
Medicines to prevent organ rejection after transplantation such as cyclosporine.
Diuretics such as furosemide.
Medicines that can increase the amount of potassium in the blood such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with
sulfamethoxazole (for infections) and heparin (used to thin the blood)
Steroid medicines for treating inflammation such as prednisolone.
Allopurinol (used to lower uric acid levels in the blood).
Procainamide (for heart rhythm problems).
Medicines used to prevent organ rejection and to treat cancer (such as
temsirolimus, sirolimus, everolimus).
Vildagliptin, a medicine used to treat diabetes.
Racecadotril, a medicine used to treat diarrhea.
In particular, tell your doctor or pharmacist if you are taking, have recently taken or might
take any of the following medicines:
Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that
may increase the amount of potassium in the blood (such as trimethoprim and cotrimoxazole for
treating bacterial infections; cyclosporine, an immunosuppressant medicine used to prevent
organ rejection; and heparin, a medicine used to thin the blood and prevent
blood clots).
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 reported in the section
"Do not take RAMIPRIL ALMUS" and "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 ALMUS:
Diabetes medicines such as oral hypoglycemic agents and insulin. RAMIPRIL ALMUS can
lower blood sugar levels. Carefully monitor your blood sugar levels when taking RAMIPRIL ALMUS.
Lithium (for mental health problems). RAMIPRIL ALMUS can increase the amount of lithium in
the blood. Your doctor must carefully monitor your lithium levels in the blood.
If any of the conditions described above occur (or you are unsure), ask your doctor before taking
RAMIPRIL ALMUS.

RAMIPRIL ALMUS with food and alcohol
Drinking alcoholic beverages with RAMIPRIL ALMUS may cause dizziness or
lightheadedness. If you want to know how much alcohol to drink when taking RAMIPRIL ALMUS, discuss
it with your doctor, as medicines used to lower blood pressure and alcohol can
have additive effects.
RAMIPRIL ALMUS can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy
You must tell your doctor if you think you may be pregnant (or might become pregnant).
You must not take RAMIPRIL ALMUS in the first 12 weeks of pregnancy, and you must not take it at all from the 13th week because its use during pregnancy can be harmful to the baby.
If you become pregnant while taking RAMIPRIL ALMUS, tell your doctor immediately.
Before planning a pregnancy, you must switch to another more suitable medicine.

Breastfeeding
You must not take RAMIPRIL ALMUS if you are breastfeeding. Ask your doctor or pharmacist
before taking any medicine.

Driving and using machines
You may feel dizzy while taking RAMIPRIL ALMUS. This is more likely when
you have just started taking RAMIPRIL ALMUS or have just increased the dose. If this
happens, do not drive or use tools or machinery.

RAMIPRIL ALMUS contains lactose and sodium
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this
medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take RAMIPRIL ALMUS

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.

How much to take

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 amount you take 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 amount before
starting you on treatment with RAMIPRIL ALMUS.

To reduce the risk of a heart attack or stroke
The usual starting dose is 2.5 mg once a day.
Your doctor may decide to increase the dosage you take.
The usual dose is 10 mg once a day.

Treatment to reduce or delay the worsening of kidney problems
You may be given to start with a dose of 1.25 mg or 2.5 mg once a day
Your doctor will adjust the amount you are taking.
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 adjust the amount you take.
The maximum dose is 10 mg per day. It is preferable to divide the dose into two administrations
daily.

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 adjust the amount you take.
The usual dose is 10 mg per day. It is preferable to divide the dose into two administrations
daily.

Elderly population
Your doctor will reduce the starting dose and adjust the treatment more slowly.

Taking this medicine
Take this medicine by mouth, at the same time of day, every day.
Swallow the tablets whole with liquid.
Do not break or chew the tablets.

If you take more RAMIPRIL ALMUS than you should
Tell your doctor or go to the nearest hospital emergency room. Do not drive to the hospital, get
someone to take you or call an ambulance. Bring the medicine box with you. This
is because the doctor needs to know what you have taken.

If you forget to take RAMIPRIL ALMUS

• If you forget a dose, take your normal dose when it is time.
• Do not take a double dose to make up for a missed tablet.

If you have any further questions 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.

Stop taking RAMIPRIL ALMUS and contact your doctor immediately if you notice the appearance of any serious side effect- you may need urgent medical treatment:
Swelling of the face, lips or throat making it difficult to swallow or breathe, as well as itching or rash. This could be a sign of a severe allergic reaction to
RAMIPRIL ALMUS.
Severe skin reactions including rash, mouth sores, worsening of a pre-existing skin condition, redness, blistering and peeling skin (such as Stevens-Johnson Syndrome, toxic epidermal necrolysis or erythema multiforme).

Inform your doctor immediately if you experience:
Accelerated heartbeat, 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.
Easier bruising, prolonged bleeding more than usual, any sign of bleeding (e.g. bleeding gums) purple spots on the skin or increased susceptibility to infections, sore throat and fever, feeling tired, weak, dizziness or pale skin. These may be signs of circulatory or bone marrow problems.
Severe stomach pain that may extend to the back. This may be a sign of pancreatitis (inflammation of the pancreas).
Fever, chills, fatigue, loss of appetite, stomach pain, feeling unwell, 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:
Inform your doctor if any of the following conditions becomes severe or persists for more than a few days:

Common(may affect up to 1 in 10 people)
Headache or feeling tired
Feeling dizzy. This is more likely to happen when therapy with RAMIPRIL
ALMUS is just started or has just been increased
Weakness, hypotension (unusually low blood pressure), especially when standing up or getting up quickly
Dry, irritating cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath
Stomach or intestinal pain, diarrhea, indigestion, feeling unwell or malaise
Rash with or without swelling
Chest pain
Muscle cramps or pain
Blood tests show a higher than normal level of potassium.

Uncommon(may affect up to 1 in 100 people)
Problems with balance (dizziness)
Itching and unusual skin sensations such as numbness, tingling, burning, prickling or chafing (paresthesia)
Loss or change of taste
Sleep problems
Depressed mood, anxiety, increased nervousness than usual or irritability
Blocked nose, difficulty breathing or worsening of asthma
Swelling of the intestine called “intestinal angioedema” and 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 than usual
Loss or decrease of appetite (anorexia)
Fast or irregular heartbeat
Swollen arms and legs. This may be a sign that your body is retaining more water than usual
Hot flashes
Blurred vision
Joint pain
Fever
Impotence in males, reduced sexual desire in men and women
Increased number of white blood cells (eosinophilia) found during blood tests
Changes in liver, pancreas or kidney function highlighted by blood tests

Rare(may affect up to 1 in 1000 people)
Feeling faint or confused
Swollen and red tongue
Severe flaking or peeling of the skin, itching, rash characterized by pustules
Problems with nails (such as loss or separation of the nail from its bed)
Rash or bruising
Spots on the skin and cold extremities
Red, swollen, watery or itchy eyes
Hearing disorders and ringing in the ears
Feeling of weakness
Decrease in the number of red blood cells, white blood cells and platelets or hemoglobin concentration, highlighted by blood tests.

Very rare(may affect up to 1 in 10000 people)
Increased sensitivity to the sun.

Other side effects observed:
Inform your doctor if any of the following conditions becomes severe or persists for more 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
Concentrated urine (dark colored), feeling unwell or malaise, muscle cramps, confusion and convulsions which may be due to inappropriate secretion of ADH (antidiuretic hormone). If you experience these symptoms contact your doctor promptly.
Fingers of the hands and feet that change color when cooled and tingle or hurt when warmed (Raynaud's phenomenon)
Increased breast volume in men
Slowed or altered reactions
Burning sensation
Change in the perception of smells
Hair loss.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 ALMUS

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C.
Do not use this medicine after the expiry date which is stated on the packaging and on the blister after Exp.
The expiry date refers to the last day of that month.
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 ALMUS contains
The active ingredient is ramipril.
The other ingredients are: sodium hydrogen carbonate, lactose monohydrate, sodium croscarmellose, pregelatinized starch,
sodium stearylfumarate, yellow iron oxide (E172) (only in 2.5 and 5 mg tablets),
red iron oxide (E 172) (only in 5 mg tablets).

Description of the appearance of RAMIPRIL ALMUS and package contents
RAMIPRIL ALMUS 2.5 mg: yellow, capsule-shaped, flat, uncoated tablets, 10.0 x 5.0 mm with
a fracture line on one side and on the edge, with the inscription “R2”.
RAMIPRIL ALMUS 5 mg: pink, capsule-shaped, flat, uncoated tablets, 8.8 x 4.4 mm with a fracture line
on one side and on the edge with the inscription “R3”.
RAMIPRIL ALMUS 10 mg: white to off-white, capsule-shaped, flat, uncoated tablets,
11.0 x 5.5 mm with a fracture line on one side and on the edge with the inscription “R4”.
Packs of:
Blisters: 10, 14, 20, 28, 30, 42, 50, 98 and 100 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers

Marketing Authorisation Holder
Almus S.r.l.
Via Cesarea 11/10
16121 Genova
E-mail: [email protected]

Manufacturer responsible for batch release
Actavis Ltd.
BLB016, Bulebel Industrial Estate, Zejtun ZTN 3000
Malta
Actavis hf.
Reykjavíkurvegur 78
IS-220 Hafnarfjörður
Iceland
Balkanpharma - Dupnitsa AD
3 Samokovsko Schosse Str.
Dupnitsa 2600
Bulgaria