Unipril

Package leaflet: Information for the user

UNIPRIL 2.5 mg tablets, 5 mg tablets, 10 mg tablets

ramipril
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 their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What UNIPRIL is and what it is used for

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

• Reducing the body's production of substances that may cause an increase in blood pressure
• Relaxing and widening your blood vessels
• Helping your heart pump blood around the body.

UNIPRIL may 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 your heart when it is unable to pump an adequate amount of blood to the rest of the body (heart failure)
• As a treatment after a heart attack (myocardial infarction) when associated with heart failure.

2. What you should know before taking UNIPRIL

Do not take UNIPRIL:

• If you are allergic to ramipril, to any other ACE inhibitor medicine, 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 ever had a severe allergic reaction called "angioedema". These 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 concurrently being treated with sacubitril/valsartan (for long-term treatment of heart failure).
• If you are undergoing dialysis or any other type of blood filtration. Depending on the equipment used, UNIPRIL 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 section below “Pregnancy and breastfeeding”).
• If your blood pressure is excessively low or unstable. Your doctor will need to 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 UNIPRIL if any of the above conditions apply to you. If you are unsure, consult your doctor before taking UNIPRIL.

Warnings and precautions

Talk to your doctor or pharmacist before taking UNIPRIL:

• If you have heart, liver, or kidney problems.
• If you have lost significant amounts of body salts or fluids (due to illness such as vomiting, diarrhoea, excessive sweating, or following a low-salt diet, or due to long-term use of oral diuretics, or after undergoing dialysis).
• If you are taking medicines called mTOR inhibitors (e.g., temsirolimus, everolimus, sirolimus), or vildagliptin, or neprilysin inhibitors (NEP) (e.g., racecadotril and sacubitril/valsartan), as these may increase the risk of angioedema, a severe allergic reaction.
• If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitisation).
• If you are about to undergo anaesthesia. This may be administered for a surgical or dental procedure. You may need to stop taking UNIPRIL the day before; consult your doctor.
• If you have high levels of potassium or low levels of sodium in your blood (as shown by a blood test).
• If you have a collagen vascular disease such as scleroderma or systemic lupus erythematosus.
• You must inform your doctor if you think you are pregnant (or if there is any chance you could become pregnant). UNIPRIL 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 “Pregnancy and breastfeeding”.
• If you are taking any of the following medicines used to treat 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 levels of electrolytes (e.g., potassium) in your blood at regular intervals.

See also the information under the heading "Do not take UNIPRIL".

Children

The use of UNIPRIL is not recommended in children and adolescents under 18 years of age, as there is insufficient information available in this population.

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

Other medicines and UNIPRIL

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because UNIPRIL may affect the action of some other medicines, and some medicines may affect the action of UNIPRIL. Your doctor may need to adjust your dose and/or take other precautions.

Do not use UNIPRIL with sacubitril/valsartan (for long-term treatment of heart failure).

Inform your doctor if you are taking any of the following medicines. These medicines may interfere with UNIPRIL 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 will need to monitor your blood pressure.

Inform your doctor if you are taking any of the following medicines. Taking these with UNIPRIL 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, indometacin, aspirin).
• Medicines for cancer (chemotherapy).
• Temsirolimus (for cancer treatment).
• Medicines to prevent organ rejection after transplant, such as ciclosporin.
• Sirolimus (to prevent transplant rejection).
• Everolimus (to prevent transplant rejection and for cancer treatment).
• Diuretics such as furosemide.
• Medicines that may increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (for infections), and heparin (used to make the blood less likely to clot).
• Steroid medicines for treating inflammation, such as prednisolone.
• Allopurinol (used to lower uric acid levels in the blood).
• Procainamide (for heart rhythm problems).
• An angiotensin II receptor antagonist (AIIRA) or aliskiren (see also section "Do not take UNIPRIL" and "Warnings and precautions").
• Vildagliptin (for the treatment of type 2 diabetes).
• Racecadotril (used to treat diarrhoea).
• Sacubitril/valsartan (for long-term treatment of heart failure).

Inform your doctor if you are taking any of the following medicines. The action of these medicines may be affected by UNIPRIL:

• Medicines for diabetes, such as oral hypoglycaemics and insulin. UNIPRIL may lower blood sugar levels. Monitor your blood sugar levels carefully when taking UNIPRIL.
• Lithium (for psychiatric conditions). UNIPRIL may increase lithium levels in the blood. Your doctor must monitor your blood lithium levels closely.

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

UNIPRIL with food and alcohol

• Drinking alcoholic beverages together with UNIPRIL may cause dizziness or drowsiness. If you want to know how much alcohol you can drink while taking UNIPRIL, discuss this with your doctor, as blood pressure-lowering medicines and alcohol may have additive effects.
• UNIPRIL can be taken with or without food.

Pregnancy and breastfeeding

You must inform your doctor if you think you are pregnant (or if there is any chance you could become pregnant). You should not take UNIPRIL during the first 12 weeks of pregnancy, and you must not take it at all from the 13th week onwards, as its use during pregnancy may harm the unborn child.

Inform your doctor immediately if you become pregnant while being treated with UNIPRIL. Before planning a pregnancy, you should switch to an appropriate alternative treatment.

Do not take UNIPRIL if you are breastfeeding.

Ask your doctor or pharmacist before taking any medicine.

Driving and using machines

You may feel dizzy while taking UNIPRIL. This is more likely when you first start taking UNIPRIL or when your dose has just been increased. If this occurs, do not drive or operate tools or machinery.

UNIPRIL contains sodium

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

3. How to take UNIPRIL

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Taking 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

How much to take
Treatment of high blood pressure

• The recommended 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 UNIPRIL.
  To reduce the risk of heart attack or stroke
• The recommended starting dose is 2.5 mg once daily.
• Your doctor may decide to increase your dose.
• The usual 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 recommended starting dose is 1.25 mg once daily.
• Your doctor will adjust your dose accordingly.
• 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 recommended starting dose ranges from 1.25 mg once daily to 2.5 mg twice daily.
• Your doctor will adjust your dose accordingly.
• 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 treatment more slowly.

If you take more UNIPRIL than you should
Inform your doctor or go to the nearest hospital emergency department immediately. Do not drive yourself—have someone drive you or call an ambulance. Bring the medicine pack with you. This is important so the doctor knows what you have taken.

If you forget to take UNIPRIL

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

If you have any 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 everyone gets them.
Stop taking UNIPRIL 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 UNIPRIL
• Severe skin reactions including rash, mouth ulcers, worsening of pre-existing skin conditions, 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 including heart attack and stroke
• Shortness of breath or cough. These may be signs of lung problems
• Easy bruising, bleeding that lasts longer 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, fainting, dizziness or pale appearance. These may be signs of blood or bone marrow problems
• Severe stomach pain that may extend to the back. This could be a sign of pancreatitis (inflammation of the pancreas)
• Fever, chills, tiredness, 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 become severe or persist for longer than a few days:
Common (affects less than 1 in 10 people)

• Headache or feeling tired
• Dizziness. This is more likely to occur when treatment with UNIPRIL has just started or when the dose has just been increased
• Fainting, hypotension (unusually low blood pressure), especially when standing up or getting up quickly
• Dry, persistent cough, inflammation of the sinuses (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 (affects less than 1 in 100 people)

• Balance problems (dizziness)
• Itching and unusual skin sensations such as numbness, tingling, burning, prickling or crawling sensations (paraesthesia)
• Loss or change in taste
• Sleep problems
• Depressed mood, anxiety, increased nervousness or restlessness compared to usual
• Blocked nose, difficulty breathing or worsening of asthma
• Swelling in the intestine 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
• Swollen arms and legs. This may be a sign that 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
• Increase in the number of white blood cells (eosinophilia) detected in blood tests
• Changes in liver, pancreas or kidney function shown by blood tests.

Rare (affects less than 1 in 1,000 people)

• Feeling of tremor or confusion
• 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 disorders and tinnitus
• Feeling of weakness
• Decrease in the number of red blood cells, white blood cells and platelets or in haemoglobin concentration, shown by blood tests.
  Very rare (affects less than 1 in 10,000 people)
• Increased sensitivity to sunlight.

Other reported side effects:
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
• Fingers of hands and feet changing colour when cold, and tingling or hurting when warmed up (Raynaud's phenomenon)
• Breast enlargement in men
• Slowed or altered reactions
• Burning sensation
• Changes in the perception of smells
• 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 UNIPRIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (Exp) stated on the blister and carton.
The expiry date refers to the last day of that month.
Do not dispose of medicines 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 UNIPRIL contains

• The active substance is ramipril.
• The other components are: hypromellose, pregelatinized corn starch, microcrystalline cellulose, sodium stearyl fumarate. Additionally:
• The 2.5 mg tablet contains yellow iron oxide (E172).
• The 5 mg tablet contains red iron oxide (E172).

UNIPRIL is available in three dosage strengths containing 2.5 mg, 5 mg, and 10 mg of ramipril.
Description of the appearance of UNIPRIL and package contents
2.5 mg tablet:
yellow, oval-shaped tablet, 8x4 mm, with a score line on both sides, marked
“2.5/company logo” on one side and “HMR/2.5” on the other.
5 mg tablet:
light red, oval-shaped tablet, 8x4 mm, with a score line on both sides, marked
“5/company logo” on one side and “HMP/5” on the other.
10 mg tablet:
white, oval-shaped tablet, 7x4.5 mm, with a score line on both sides, marked
“HMO/HMO” on one side.
Unipril tablets are available in blister packs of 14, 20, 28, and 100 tablets.
Packages containing 28 tablets may also be available in calendar blister packs.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Global Pharmacies Partners S.r.l.
Via Cesare Battisti 1, 20122 Milan, Italy
Manufacturer
Sanofi-aventis S.p.A. - Scoppito (L'Aquila)
This medicinal product is authorized in the European Economic Area countries with the
following names:
Italy:
Unipril 2.5 mg tablets, Unipril 5 mg tablets, Unipril 10 mg tablets
This patient information leaflet does not contain all the information available on this medicine. If you have further questions or
are unsure about anything, please consult your doctor or pharmacist.
Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (AIFA): https://www.aifa.gov.it/ .