PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

RAMIPRIL ALMUS 2.5 mg, 5 mg or 10 mg tablets

Generic Medicine
Please read this leaflet carefully before 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:

What RAMIPRIL ALMUS is and what it is used for
What you need to know before taking RAMIPRIL ALMUS
How to take RAMIPRIL ALMUS
Possible side effects
How to store RAMIPRIL ALMUS
Contents of the pack and other information

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

RAMIPRIL ALMUS contains a medicine called ramipril, which belongs to a group of medicines known as ACE inhibitors (Angiotensin-Converting Enzyme inhibitors).
RAMIPRIL ALMUS works by:
Reducing the body's production of substances that can cause an increase in blood pressure
Relaxing and widening your blood vessels
Helping your heart to pump blood around the body more easily.
RAMIPRIL ALMUS can be used:
To treat high blood pressure (hypertension)
To reduce the risk of heart attack or stroke
To reduce the risk of or delay the worsening of kidney problems (with or without diabetes)
To treat heart failure (when your heart cannot pump enough blood to the rest of the body)
As a treatment after a heart attack (myocardial infarction), when associated with heart failure.

2. What you should know before taking RAMIPRIL ALMUS

Do not take RAMIPRIL ALMUS:
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 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 taking or have recently taken sacubitril/valsartan, a medicine used to treat a type of chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling beneath the skin, such as in the throat).
If you are undergoing dialysis or any other type of blood filtration. Depending on the equipment 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. 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.
Do not take RAMIPRIL ALMUS if any of the above conditions apply to you. If you are unsure, consult 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.
You have lost significant amounts of body salts or fluids (due to illness such as vomiting, diarrhoea, excessive sweating, a low-salt diet, long-term use of diuretics, or after dialysis).
You are about to undergo treatment to reduce allergy to bee or wasp stings (desensitisation).
You are about to receive an anaesthetic, which may be given during surgery or dental procedures. You may need to stop taking RAMIPRIL ALMUS the day before. Consult your doctor.
You have high levels of potassium in your blood (shown by a blood test).
You are taking medicines or have conditions that may lower your blood sodium levels. Your doctor may order regular blood tests, especially to monitor your blood sodium levels, particularly if you are elderly.
You are taking any of the following medicines, as they may increase the risk of angioedema: medicines used to prevent rejection of transplanted organs or to treat cancer (such as temsirolimus, everolimus, sirolimus), vildagliptin (a medicine used to treat diabetes), racecadotril (a medicine used to treat diarrhoea), or sacubitril/valsartan. For sacubitril/valsartan, see section 2 "Do not take RAMIPRIL ALMUS".
You have a vascular collagen disease such as scleroderma or systemic lupus erythematosus.
You think you may be pregnant (or could become pregnant). RAMIPRIL ALMUS is not recommended during the first 3 months of pregnancy and may cause severe harm to the unborn baby after 3 months of pregnancy (see below "Pregnancy and breastfeeding").
You are taking any of the following medicines for high blood pressure:

an "angiotensin II receptor antagonist" (AIIRA), 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 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 above conditions apply to you (or you are unsure), consult 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 may affect the action of certain other medicines, and some medicines may affect the action of RAMIPRIL ALMUS.
Inform your doctor if you are taking any of the following medicines, as they may interfere with RAMIPRIL ALMUS and alter its effect:
Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indometacin, aspirin).
Medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. Your doctor should monitor your blood pressure.

Inform your doctor if you are taking any of the following medicines, as they may increase the risk of side effects when taken with RAMIPRIL ALMUS:
Sacubitril/valsartan – used to treat a type of chronic heart failure in adults (see section 2 "Do not take RAMIPRIL ALMUS").
Medicines used to relieve pain and inflammation (e.g. NSAIDs such as ibuprofen, indometacin, aspirin).
Cancer medicines (chemotherapy).
Medicines to prevent organ transplant rejection, such as ciclosporin.
Diuretics such as furosemide.
Medicines that may increase blood potassium levels, 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 used to treat inflammation, such as prednisolone.
Allopurinol (used to lower uric acid levels in the blood).
Procainamide (for heart rhythm problems).
Medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus).
Vildagliptin, a medicine used to treat diabetes.
Racecadotril, a medicine used to treat diarrhoea.

In particular, inform your doctor or pharmacist if you are taking, have recently taken, or might take any of the following:
Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (such as trimethoprim and cotrimoxazole for bacterial infections; ciclosporin, an immunosuppressant used to prevent transplant rejection; and heparin, a medicine used to thin the blood and prevent clots).
Your doctor may need to adjust the dose and/or take additional precautions if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also "Do not take RAMIPRIL ALMUS" and "Warnings and precautions").

Inform your doctor if you are taking any of the following medicines, as their action may be affected by RAMIPRIL ALMUS:
Diabetes medicines such as oral hypoglycaemics and insulin. RAMIPRIL ALMUS may lower blood sugar levels. Monitor your blood sugar levels carefully when taking RAMIPRIL ALMUS.
Lithium (for psychiatric conditions). RAMIPRIL ALMUS may increase lithium levels in the blood. Your doctor must closely monitor your blood lithium levels.
If any of the above conditions apply to you (or you are unsure), consult your doctor before taking RAMIPRIL ALMUS.

RAMIPRIL ALMUS with food and alcohol
Drinking alcohol while taking RAMIPRIL ALMUS may cause dizziness or lightheadedness. Discuss with your doctor how much alcohol is safe to drink while taking RAMIPRIL ALMUS, as blood pressure-lowering medicines and alcohol may have additive effects.
RAMIPRIL ALMUS may be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you may be pregnant (or could become pregnant).
You must not take RAMIPRIL ALMUS during the first 12 weeks of pregnancy and must not take it at all from week 13 onwards, as its use during pregnancy may harm the unborn baby.
If you become pregnant while taking RAMIPRIL ALMUS, inform your doctor immediately.
Before planning a pregnancy, you should switch to a more suitable medicine.

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

Driving and using machines
You may experience dizziness while taking RAMIPRIL ALMUS. This is more likely when you first start taking it or when your dose has just been increased. If this occurs, do not drive or operate tools or machinery.

RAMIPRIL ALMUS contains lactose and sodium
If your doctor has diagnosed you with an 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 instructed by your doctor or pharmacist.
If you are unsure, you should ask your doctor or pharmacist for advice.
How much to take
Treatment of high blood pressure
The usual starting dose is 1.25 mg or 2.5 mg once daily.
Your doctor will adjust your 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 or reduce them before starting your treatment with RAMIPRIL ALMUS.
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 your dose.
The usual maintenance dose is 10 mg once daily.
Treatment to reduce or delay worsening of kidney problems
You may be started on a dose of 1.25 mg or 2.5 mg once daily.
Your doctor will adjust your dose accordingly.
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 your dose.
The maximum dose is 10 mg per day. It is preferable to divide the daily dose into two 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 adjust your dose.
The usual dose is 10 mg per day. It is preferable to divide the dose into two daily administrations.
Elderly population
Your doctor will reduce the initial dose and adjust treatment more slowly.
How to take this medicine
Take this medicine by mouth, at the same time each day.
Swallow the tablets whole with liquid.
Do not break or chew the tablets.
If you take more RAMIPRIL ALMUS than you should
Contact your doctor or go to the nearest hospital emergency department immediately. Do not drive yourself—have someone drive you or call an ambulance. Take the medicine pack with you so the doctor knows what you have taken.
If you forget to take RAMIPRIL ALMUS

If you miss a dose, take your usual dose at the next scheduled 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 will experience them.
Stop taking RAMIPRIL ALMUS and contact your doctor immediately if you notice any of the following serious side effects –
you may need urgent medical treatment:
Swelling of the face, lips, or throat causing difficulty swallowing or breathing, as well as itching or skin rash. This could be a sign of a severe allergic reaction to RAMIPRIL ALMUS.
Severe skin reactions including rash, mouth ulcers, worsening of pre-existing skin disorders, redness, blistering, and peeling of the skin (such as 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.
Easier bruising, prolonged bleeding more than usual, any sign of bleeding (e.g. bleeding gums), purple spots on the skin, increased susceptibility to infections, sore throat, fever, feeling tired, weak, dizzy, or pale appearance. These may be signs of blood or bone marrow problems.
Severe stomach pain that may spread to the back. This could 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 (liver inflammation) or liver damage.
Other side effects include:
Inform your doctor if any of the following conditions become severe or last longer than a few days:
Common (may affect up to 1 in 10 people)
Headache or feeling tired
Dizziness. This is more likely when treatment with RAMIPRIL ALMUS has just started or the dose has recently been increased
Weakness, hypotension (unusually low blood pressure), especially when standing up or rising quickly
Dry, persistent cough, sinus inflammation (sinusitis), or bronchitis, shortness of breath
Stomach or intestinal pain, diarrhoea, indigestion, nausea or feeling unwell
Skin rash with or without swelling
Chest pain
Muscle cramps or muscle pain
Blood tests show 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 stinging (paraesthesia)
Loss or change in taste
Sleep problems
Depressed mood, anxiety, increased nervousness, or irritability
Stuffy nose, breathing difficulties, or worsening of asthma
Intestinal swelling 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 of appetite or reduced appetite (anorexia)
Rapid or irregular heartbeat
Swollen arms and legs. This may indicate your body is retaining more fluid than usual
Hot flushes
Blurred vision
Joint pain
Fever
Impotence in men, reduced sexual desire in men and women
Increased number of white blood cells (eosinophilia) detected in blood tests
Changes in liver, pancreas, or kidney function shown by blood tests
Rare (may affect up to 1 in 1,000 people)
Feeling faint or confused
Swollen and red tongue
Severe peeling or shedding of the skin, itching, rash with pustules
Nail problems (such as nail loss or separation of the nail from its bed)
Skin rash or bruising
Spots on the skin and cold extremities
Red, swollen, watery, or itchy eyes
Hearing problems and ringing in the ears
Feeling weak
Decreased number of red blood cells, white blood cells, platelets, or haemoglobin concentration, shown by blood tests.
Very rare (may affect up to 1 in 10,000 people)
Increased sensitivity to sunlight.
Other side effects reported:
Inform your doctor if any of the following conditions become severe or persist for longer than a few days.
Difficulty concentrating
Mouth swelling
Blood tests showing too low a number of blood cells
Blood tests showing low sodium levels in the blood
Concentrated (dark-coloured) urine, feeling unwell, muscle cramps, confusion, and seizures, which may be due to inappropriate antidiuretic hormone (ADH) secretion. If you experience these symptoms, contact your doctor promptly.
Fingers of hands and feet changing colour when cold, and tingling or painful when warmed (Raynaud's phenomenon)
Breast enlargement in men
Slowed or altered reactions
Burning sensation
Changes in sense of smell
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 . Reporting side effects 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 above 25°C.
Do not use this medicine after the expiry date stated on the packaging and blister after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What RAMIPRIL ALMUS contains
The active substance is ramipril.
The other components are: sodium hydrogen carbonate, monohydrate lactose, sodium croscarmellose, pregelatinized starch, sodium stearilfumarate, yellow iron oxide (E172) (only in the 2.5 mg and 5 mg tablets), red iron oxide (E 172) (only in the 5 mg tablets).

Description of the appearance of RAMIPRIL ALMUS and package contents
RAMIPRIL ALMUS 2.5 mg: yellow, capsule-shaped, flat, film-coating-free tablets, 10.0 x 5.0 mm, with a break line on one side and on the edge, engraved with the code “R2”.
RAMIPRIL ALMUS 5 mg: pink, capsule-shaped, flat, film-coating-free tablets, 8.8 x 4.4 mm, with a break line on one side and on the edge, engraved with the code “R3”.
RAMIPRIL ALMUS 10 mg: white to off-white, capsule-shaped, flat, film-coating-free tablets, 11.0 x 5.5 mm, with a break line on one side and on the edge, engraved with the code “R4”.

Pack sizes:
Blister packs: 10, 14, 20, 28, 30, 42, 50, 98 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturers
Marketing Authorization Holder
Almus S.r.l.
Via Cesarea 11/10
16121 Genoa
Email: [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