UNIPRIL 2.5 mg Tabletki powlekane

Treść ulotki

1. UNIPRIL 2.5 mg tablets, 5 mg tablets, 10 mg tablets
   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

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

ramipril

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, 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 you take 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 the group of medicines called
ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).
UNIPRIL works by:

• Decreasing the production, by the body, of substances that can cause an increase in blood pressure
• Relaxing and widening its blood vessels
• Helping its heart to pump blood around the body.

UNIPRIL 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 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 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”. These signs include itching, rash (hives), 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 already taking sacubitril/valsartan (for long-term treatment of heart failure)
• If you are having dialysis or are undergoing any other type of blood filtration. Depending on the machine being used, UNIPRIL may not be suitable for you
• If you have kidney problems caused by 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 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 UNIPRIL if any of the above conditions apply to you. If you are not sure, ask 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 a lot of salts or body fluids (due to an illness such as vomiting, diarrhoea, excessive sweating, or following a low-salt diet, or after taking diuretics for a long time or having undergone dialysis).
• If you are taking medicines called mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus), or vildagliptin or neprilysin (NEP) inhibitors (e.g. racecadotril and sacubitril/valsartan) as they may increase the risk of angioedema, a serious allergic reaction.
• If you are about to undergo treatment to reduce your allergy to bee or wasp stings (desensitisation).
• If you are about to have an anaesthetic. This may be given for surgery or dental treatment. You may need to stop taking UNIPRIL the day before, ask your doctor for advice.
• If you have a high amount of potassium or a low amount of sodium in your blood (shown by a blood test).
• If you have a connective tissue disease of the blood vessels such as scleroderma or systemic lupus erythematosus.
• You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). UNIPRIL 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 “Pregnancy and breastfeeding”.
• If you are taking any of the following medicines used to treat high blood pressure:
• an “angiotensin II receptor blocker” (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 stated under "Do not take Unipril”.

Children
The use of UNIPRIL is not recommended in children and adolescents under 18 years of age because
there is no information available in this population.
If any of the above conditions apply to you (or you are not sure), ask 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 can affect the way some other medicines work. Also some medicines can affect the way UNIPRIL works. Your
doctor may need to change your dose and/or take other precautions.
Do not use UNIPRIL with sacubitril/valsartan (for the long-term treatment of heart failure)
Tell your doctor if you are taking any of the following medicines. These medicines can interfere
with UNIPRIL by altering its action:

• 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 check your blood pressure.

Tell your doctor if you are taking any of the following medicines. These medicines, if taken with
UNIPRIL, can 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)
• Cancer medicines (chemotherapy)
• Temsirolimus (for cancer treatment)
• Medicines to prevent organ rejection after transplantation such as ciclosporin
• Sirolimus (for transplant rejection prevention)
• Everolimus (for transplant rejection prevention and cancer treatment)
• Diuretics such as furosemide
• Medicines that can increase the amount of potassium in your blood such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (for infections) and heparin (used to make the blood more fluid)
• Steroid medicines for treating inflammation such as prednisolone
• Allopurinol (used to lower the amount of uric acid in the blood)
• Procainamide (for heart rhythm problems)
• An angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is stated under "Do not take Unipril” and “Warnings and precautions”).
• Vildagliptin (for treating type 2 diabetes mellitus)
• Racecadotril (used to treat diarrhoea)
• Sacubitril/valsartan (for the long-term treatment of heart failure)

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

• Diabetes medicines such as oral hypoglycaemics and insulin. UNIPRIL can lower the amount of sugar in your blood. Check your blood sugar level carefully when taking UNIPRIL
• Lithium (for psychiatric problems). UNIPRIL can increase the amount of lithium in your blood. Your doctor must check your blood lithium level carefully. If any of the above conditions apply to you (or you are not sure), ask your doctor before taking UNIPRIL.

UNIPRIL with food and alcohol

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

Pregnancy and breastfeeding
You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). You should not take UNIPRIL during the first 12 weeks of pregnancy, and you must not
take it at all from the thirteenth week onwards as use during pregnancy could be harmful to the baby.
Tell your doctor immediately if you become pregnant while taking UNIPRIL. In
advance of a planned pregnancy, you should be switched to an appropriate alternative treatment.
You must 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 have just increased the dose. If this happens, do not
drive or use tools or machines.

UNIPRIL contains sodium
UNIPRIL contains less than 1 mmol (23 mg) of sodium per tablet, that is to say it is essentially ‘sodium-free’.

3. How to take UNIPRIL

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your doctor or pharmacist.

Taking this medicine

• Take this medicine by mouth at the same time of day, every day
• Swallow the tablets whole with some 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 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 UNIPRIL. To reduce the risk of a heart attack or stroke
• The recommended 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 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 recommended 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 daily administrations. Treatment after a heart attack
• The recommended 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 daily administrations. Elderly peopleYour doctor will reduce the starting dose and adjust the treatment more slowly.

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

If you forget to take UNIPRIL

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

If you have any further questions on 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 everybody 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 that makes it difficult to swallow or breathe, as well as itching or rash. This could be a sign of a severe allergic reaction to UNIPRIL
• Severe skin reactions including rash, mouth sores, worsening of a pre-existing skin condition, redness, blistering and peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

Tell your doctor immediately if you experience:

• Fast 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 can be signs of lung problems
• Easier bruising, prolonged bleeding than normal, any sign of bleeding (e.g. bleeding gums) purple spots on the skin or easy onset of infections, sore throat and fever, feeling tired, fainting, dizziness or pale skin. These can be signs of problems with blood circulation or bone marrow
• 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 can be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage.

Other side effects include:
Tell your doctor if any of the following conditions becomes severe or persists for more than a few days:

Common(affects less than 1 in 10 people)

• Headache or feeling tired
• Feeling dizzy. This is more likely to happen when treatment with UNIPRIL is first started or has just been increased
• Fainting, low blood pressure (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 sick or unwell
• Rash with or without swelling
• Chest pain
• Muscle cramps or pain
• Blood tests show a higher than normal level of potassium.

Not common(affects less than 1 in 100 people)

• Problems with balance (vertigo)
• Itching and unusual skin sensations such as numbness, tingling, burning, prickling or crawling (paresthesia)
• Loss or change of taste
• Sleep problems
• Depressed mood, anxiety, increased nervousness than usual or restlessness
• Blocked nose, difficulty breathing or worsening of asthma
• Swelling of the intestines 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
• Arms and legs swelling. This may be a sign that your body is retaining more water 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 in the blood (eosinophilia) found during blood tests
• Changes in liver, pancreas or kidney function highlighted by blood tests.

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

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

Other side effects reported:
Tell 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 low number of blood cells
• Blood tests showing a low level of sodium in the blood
• Fingers and toes that change color when cooled and that 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 UNIPRIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (Exp) which is stated on the blister and the carton. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What UNIPRIL contains

• The active ingredient is ramipril
• The other ingredients are: hypromellose, pregelatinized corn starch, microcrystalline cellulose, sodium stearylfumarate. Also:
• The 2.5 mg tablet contains yellow iron oxide (E172)
• The 5 mg tablet contains red iron oxide (E172)

UNIPRIL is available in three dosages containing 2.5 mg, 5 mg and 10 mg of ramipril.

Description of the appearance of UNIPRIL and contents of the pack
2.5 mg tablet:
yellow-colored, oblong tablet, 8x4 mm with a fracture line on both sides, imprinted with
“2.5/holder’s logo” on one side and “HMR/2.5” on the other.
5 mg tablet:
light red-colored, oblong tablet, 8x4 mm with a fracture line on both sides, imprinted with
“5/holder’s logo” on one side and “HMP/5” on the other.
10 mg tablet:
white-colored, oblong tablet, 7x4.5 mm with a fracture line on both sides, imprinted with
“HMO/HMO” on one side.
Unipril tablets are available in blister packs of 14, 20, 28 and 100 tablets.
Packs of 28 tablets may also be available in calendar blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Global Pharmacies Partners S.r.l.
Via Cesare Battisti 1. 20122 Milano

Manufacturer
Sanofi-aventis S.p.A. - Scoppito (L'Aquila)

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Italy:
Unipril 2.5 mg tablets, Unipril 5 mg tablets, Unipril 10 mg tablets
if you are not sure about something, ask your doctor or pharmacist.

Other sources of information
More detailed information on this medicine is available on the website of the Italian Medicines Agency (AIFA): https://www.aifa.gov.it/ .