TRANDOLAPRIL 0.5 MG Kapsułki twarde

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1. Trandolapril Mylan Generics 0.5 mg, 2 mg hard capsules
   1. What you need to know before taking Trandolapril Mylan Generics
   2. How to take Trandolapril Mylan Generics
   3. POSSIBLE SIDE EFFECTS
   4. How to store Trandolapril Mylan Generics
   5. Package Contents and Other Information

Trandolapril Mylan Generics 0.5 mg, 2 mg hard capsules

(Trandolapril)
Generic equivalent 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 may 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 is Trandolapril Mylan Generics and what it is used for
• 2. What you need to know before you take Trandolapril Mylan Generics
• 3. How to take Trandolapril Mylan Generics
• 4. Possible side effects
• 5. How to store Trandolapril Mylan Generics
• 6. Contents of the pack and other information
• 1.What is Trandolapril Mylan Generics and what it is used forTrandolapril, the active ingredient in Trandolapril Mylan Generics capsules, belongs to a group of medicines called angiotensin converting enzyme inhibitors (sometimes called ACE inhibitors). ACE inhibitors work by relaxing your blood vessels, which makes it easier for your heart to pump blood around your body. This helps to lower your blood pressure.

Trandolapril Mylan Generics is used to treat high blood pressure. It can also be used
to help protect your heart after a heart attack.

2. What you need to know before taking Trandolapril Mylan Generics

Do not take TrandolaprilMylan Generics:

• if you are allergic to trandolapril, to other ACE inhibitors (for example, perindopril or ramipril) or to any of the other ingredients of this medicine (listed in section 6)
• if you have had a condition called angioedema (swelling of the hands, face, lips, tongue or throat with difficulty swallowing or breathing, possibly accompanied by an itchy rash similar to hives) or hereditary angioedema (a severe allergic skin condition) after taking an ACE inhibitor
• if you or a family member has had angioedema in the past
• if you are pregnant for more than three months (it is best to avoid trandolapril even in the early stages of pregnancy - (see section Pregnancy).
• 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. If you have taken or are taking sacubitril/valsartan, a medicine used to treat a long-term (chronic) type of heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat).

Warnings and precautions
Talk to your doctor or pharmacist before taking Trandolapril Mylan Generics:

• If you have recently started taking or have been taking diuretics (water tablets) for a long time, or are following a low-sodium diet, have or have had prolonged or severe vomiting or

diarrhea or are dehydrated. In these cases, it is more likely that when you start taking the
tablets, you will experience a sharp drop in blood pressure (hypotension), which can cause
possible fainting or dizziness.

• If you suffer from narrowing of the blood vessels of one or both kidneys (renal stenosis).
• If you have a narrowing of one of the heart valves (aortic stenosis) or in the outflow from the left chamber of the heart. You should not take Trandolapril Mylan Generics. Your doctor will prescribe another medicine that is more suitable for you.
• If you suffer from a condition known as collagen vascular disease (this is sometimes called connective tissue disease, for example lupus or scleroderma). You may have changes in your blood composition that make you more likely to develop infections.
• If you are of African-Caribbean origin. Trandolapril Mylan Generics may be less effective in lowering blood pressure or may increase the risk of angioedema.
• If you suffer from diabetes mellitus. Trandolapril Mylan Generics may cause an excessive lowering of blood glucose levels.
• If you suffer from heart failure or cirrhosis of the liver with swelling that can also extend to the stomach. When you start taking the tablets, you are more likely to experience a sharp drop in blood pressure (hypotension) which can cause a feeling of weakness or dizziness.
• If you have problems with blood vessels in the brain or have had a stroke, as you will need to be closely monitored by your doctor at the start of treatment and if the dose is changed.
• If you need kidney dialysis, as you may be at risk of severe allergic reactions (some types of dialysis membranes may not be suitable). You may need to be monitored more closely by your doctor.
• If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is increased:
• sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs)
• neprilysin (NEP) inhibitors such as sacubitril (available in fixed-dose combination with valsartan), used in patients with heart failure, and racecadotril, used in patients with acute diarrhea.
• If you suffer from other liver or kidney problems or have had a kidney transplant.
• If you are over 70 years of age or have too much acid in your blood (metabolic acidosis). These can increase potassium levels in the blood, which can cause heart problems.
• If you are being treated with a medicine that lowers your immune response.
• If you are about to undergo a treatment called “LDL-apheresis” (which involves removing cholesterol from your blood using a machine).
• If you are about to undergo desensitization treatment to reduce the effects of an allergy to insect stings (such as bee or wasp stings).
• 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 the section “Do not take Trandolapril Mylan Generics”.
You must tell your doctor if you think you are pregnant (or might become pregnant). Trandolapril is not
recommended in early pregnancy, and should not be taken if you are pregnant for more than three
months as it can cause serious harm to the baby if taken during this period (see the
section Pregnancy).

During treatment with Trandolapril Mylan Generics
If you experience any of the following symptoms, you should immediately inform your doctor:

• You feel dizzy or faint after the first dose. Some people react after the first dose or after an increase in dosage, experiencing dizziness, weakness, feeling faint or unwell.
• Sudden swelling of the lips, tongue, face, throat or neck, possibly hands and feet, with difficulty breathing or swallowing. This collection of symptoms is called angioedema and can occur at any time during treatment.
• Stomach pain, sometimes also nausea or vomiting. This may be a symptom of angioedema in the stomach (intestinal angioedema).
• High temperature, sore throat or mouth ulcers (these may be symptoms of an infection caused by a decrease in the number of white blood cells).
• Yellowing of the skin and whites of the eyes (jaundice) or blood tests showing an increase in liver enzymes. These may be signs of liver disease.
• Persistent cough.

If you are going to have surgery or are going to be given an anesthetic, tell your
doctor, dentist or hospital staff that you are taking Trandolapril Mylan Generics, because
taking Trandolapril Mylan Generics at this time can cause a further drop in
blood pressure.
At the beginning of treatment and during the dose adjustment period, your doctor may request
blood tests to monitor potassium levels in the blood and kidney function.

Other medicines and TrandolaprilMylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, even those available without a prescription, herbal products or
natural remedies.
If you are undergoing therapy with Trandolapril Mylan Generics or immediately after, and are
then undergoing therapy with another medicine, remember to tell your doctor that you are taking/have
taken Trandolapril Mylan Generics. The doctor may need to adjust the dose and/or take other
precautions.
It is particularly important to inform your doctor if you use:

• NEP inhibitors such as sacubitril (available in fixed-dose combination with valsartan) and racecadotril: the risk of angioedema (rapid swelling under the skin or submucosa in areas such as the throat) is increased
• If you are taking any of the following medicines, the risk of angioedema may be increased.
• Racecadotril, a medicine used to treat diarrhea.
• Medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.
• Other medicines for the treatment of high blood pressure as they may increase the effect of trandolapril.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics (such as spironolactone, amiloride and triamterene) 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 used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent the formation of clots)
• Loop diuretics, such as torsemide and furosemide and thiazide diuretics, such as chlorothiazide and bendroflumethiazide as they can cause a sharp drop in blood pressure
• Non-steroidal anti-inflammatory pain relievers (NSAIDs - e.g. ibuprofen, diclofenac, indometacin, acetylsalicylic acid and COX-2 inhibitors), as these may decrease the effect of trandolapril.
• Lithium, a medicine used to treat mental disorders, as trandolapril may increase the levels of the drug in the body.
• Tricyclic antidepressants (e.g. amitriptyline, dosulepin), as these drugs may increase the effects of trandolapril.
• Medicines for diabetes (such as insulin, glibenclamide or gliclazide), trandolapril may cause an excessive lowering of blood glucose levels.
• Antacids, to relieve digestive problems; they should not be taken within 2 hours of taking trandolapril. This is because antacids can prevent the body from absorbing trandolapril effectively.
• Allopurinol (for gout) or procainamide (for heart rhythm abnormalities), as these may increase the risk of reducing the level of white blood cells in the body.
• Immunosuppressants (e.g. cyclosporine) that lower the body's immune response, or steroid drugs (e.g. prednisolone, hydrocortisone) or anticancer drugs (cytostatics), as these may increase the risk of reducing the level of white blood cells in the body.
• Medicines containing ephedrine, norepinephrine (noradrenaline) or epinephrine (adrenaline), as they reduce the effect of trandolapril.
• Medicines containing sodium aurothiomalate (gold) as side effects may occur more frequently.
• Opioids (strong painkillers), such as methadone, codeine and morphine as they can cause a drop in blood pressure.
• Antipsychotic drugs such as chlorpromazine, thioridazine, flupentixol, as they can cause a drop in blood pressure.
• An angiotensin II receptor blocker (AIIRA) or aliskiren (see also the section “Do not take Trandolapril Mylan Generics” and “Warnings and precautions”).
• Medicines commonly used to prevent rejection of transplanted organs (sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.

Contact your doctor and tell them if you are taking any of the medicines listed above. It may be
necessary to adjust the dose.

TrandolaprilMylan Genericswith alcohol
Drinking alcohol increases the blood pressure lowering effect of Trandolapril Mylan
Generics.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.

Pregnancy
You must tell your doctor if you think you are pregnant (or there is a possibility of becoming
pregnant). As a rule, your doctor will advise you to stop taking trandolapril before
becoming pregnant or as soon as you find out you are pregnant and will advise you to take another
medicine instead of trandolapril. Trandolapril is not recommended in early pregnancy, and should not
be taken if you are pregnant for more than three months, as it can cause serious harm to the baby if
taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Trandolapril is not
recommended for women who are breastfeeding and your doctor may choose another treatment if you
wish to breastfeed, especially if the baby is newborn or premature.

Driving and using machines
In some people, Trandolapril can cause dizziness, fainting or fatigue, especially the first
time they start taking the capsules. Do not drive vehicles, use machines or perform any
activity that requires you to stay alert for several hours after the first dose or after any increase in
the dose. Wait to see how the capsules affect you.

Trandolapril Mylan Generics contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this
medicine.

Trandolapril Mylan Genericscontains sunset yellow (E110)
This medicine may cause allergic reactions.

3. How to take Trandolapril Mylan Generics

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist. Swallow the capsules whole without chewing and with a glass
of water. Take the capsules always at the same time of day.
The number of capsules you need to take will depend on the condition you are being treated for. If you are already taking
diuretics, your doctor may tell you to reduce the dose of diuretics or even to stop taking them
before starting to take Trandolapril Mylan Generics.

Adults:
High blood pressure (hypertension):
The recommended starting dose is 0.5 mg once a day. Your doctor will probably increase this
dose to 1-2 mg/day. The maximum dose is 4 mg/day.

Patients with heart failure and hypertension:
Therapy will be initiated in hospital. The recommended starting dose is 0.5 mg once a day.

Therapy after a heart attack:
Therapy is usually started from the third day after a heart attack, usually at the minimum
dose of 0.5 mg/day. Your doctor will probably gradually increase this dose up to a
maximum of 4 mg/day.

Dose for adults previously treated with diuretics:
Diuretic therapy must be stopped at least 72 hours (3 days) before starting treatment with
Trandolapril, and/or treatment can be started with a dose of 0.5 mg once a day. Subsequently
the dose will be adjusted when the doctor detects the type of effect of the therapy.

Elderly patients:
If kidney function is normal, it will not be necessary to reduce the dose. The doctor will check blood
pressure and monitor kidney function.
However, if you are also being treated with diuretics or if you have reduced heart, liver or kidney function, caution is necessary.

Use in children and adolescents:
Trandolapril should not be given to children.

Patients with kidney problems:
The doctor will adjust the dose according to the results of laboratory tests (0.5-1 mg/day).
Patients undergoing renal dialysis: 0.5 mg/day.

Patients with liver problems:
The starting dose is 0.5 mg/day. Afterwards, the doctor may want to adjust the dose as needed.

If you take more TrandolaprilMylan Generics than you should
If you have taken too much medicine, contact your doctor, hospital or pharmacy.
Symptoms of overdose are severe reduction of blood pressure, shock, slowing of
thinking (lethargy), slowing of the pulse, electrolyte disturbances and reduced kidney
function.

If you forget to take TrandolaprilMylan Generics
Do not take a double dose to make up for the missed dose.

If you stop taking TrandolaprilMylan Generics
It is important that you continue to take the capsules until your doctor tells you to stop. Do not
stop therapy just because you feel better. If you stop taking the capsules, your condition
may worsen.
If you have any doubts 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 gets them.

Stop taking Trandolapril immediately if you experience any of the following effects and
go to hospital immediately or consult your doctor:
Rare(may affect up to 1 in 1,000 people):

• increased number of infections you may contract such as fever, severe chills, sore throat or mouth ulcers (this may indicate that you have a decrease in the number of white blood cells in your body)
• sudden collapse, numbness or weakness in the arms or legs, headache, dizziness and confusion, visual disturbances, difficulty swallowing, slurred speech, confused or loss of ability to speak (these may be signs of a stroke or transient ischemic attack (mini-stroke) caused by a clot or bleeding that interrupts the blood supply to a part of the brain)
• feeling of heaviness or tightness in the chest with chest pain and increased breathlessness on exertion (these may be signs of heart problems such as angina)
• sudden chest pain that may spread to the neck or arm, with shortness of breath and a feeling of sweating (these may be signs of a heart attack or other heart problems)
• irregular, slow or fast heartbeat, which if fast, may feel like pounding in the chest (this may produce irregular activity if displayed on an ECG device)
• a reduction in heart function, which may cause fatigue, weakness and/or fluid retention, such as swelling of the legs and ankles, difficulty breathing including coughing up “frothy” or “watery” sputum
• traces of blood in vomit (you may notice clots that look like coffee grounds)
• yellowing of the skin or whites of the eyes, dark urine, pale stools, fatigue, fever, nausea, weakness, drowsiness and abdominal pain, abnormal liver function detected by blood tests or high levels of bilirubin in the blood (these may be signs of liver problems or a blockage in the bile duct)
• sudden swelling of the lips, tongue, face, throat or neck which may lead to difficulty swallowing or breathing (these are signs of an allergic reaction)
• absence or poor production of urine, cloudy urine or blood in the urine, pain when urinating or lower back pain (these may be signs of serious kidney problems)
• congenital defects, including skin disorders and formation of abnormal blood vessels
• fatigue, shortness of breath, feeling cold in the hands and feet and pale skin, wounds that heal with difficulty (this may indicate a reduced number of red blood cells in the body)

Not known(frequency cannot be estimated based on the available data):

• red, raised, itchy skin rashes known as hives (signs of an allergic reaction)
• weakness, unexplained or abnormal bruising or bleeding or more frequent infections, potentially serious (these may be signs of a severe reduction in all types of blood cells)
• persistent constipation with a bloated stomach and discomfort (these may be signs of a bowel obstruction)
• severe stomach pain, which may radiate to the back (may indicate signs of pancreatic disorders)
• a skin condition with severe blistering and bleeding of the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome) or severe skin reactions that begin with red, painful areas, then formation of large blisters and finally with shedding of skin layers. These are accompanied by fever and chills, muscle pain and general malaise (toxic epidermal necrolysis)

Other side effects include:
Common(may affect up to 1 in 10 people):

• dizziness or headache
• low blood pressure
• general weakness
• cough with or without mucus secretion Uncommon(may affect up to 1 in 100 people):
• sleep disturbances
• decreased or lack of sexual desire
• drowsiness
• a sensation of spinning with loss of balance (also known as vertigo)
• hot flushes
• shortness of breath, sore throat, cold or flu-like symptoms (may manifest as infection, congestion or inflammation of the airways)
• may feel unwell or have intestinal problems such as diarrhea, constipation, stomach pain
• itching, skin rashes
• back pain, muscle spasms or pain in the hands and feet
• difficulty maintaining an erection
• feeling or general state of unwellness
• chest pain
• fluid retention, swelling of the hands, feet and ankles
• feeling the heart beating in the chest

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

• feeling lightheaded or dizzy when getting up from a lying or sitting position (this may be due to a sharp drop in blood pressure)
• a feeling of discomfort or burning or difficulty in urination, an increased frequency of urination (may be a sign of infection of the kidneys, bladder or ureters, the ducts that connect the kidneys to the bladder)
• an increase in the amount of urine
• high levels of fats in the blood, such as cholesterol, (may increase the risk of blood clots)
• high levels of glucose, uric acid or other nitrogenous compounds, low levels of sodium or abnormal levels of enzymes detected by blood tests
• increase or decrease in appetite
• swollen or painful joints, especially in the toes due to a build-up of crystals (gout)
• nervousness, agitation, anxiety, depression, may be a lack of interest or enthusiasm, or seeing, feeling or hearing things that do not exist
• fainting, muscle contractions, tingling in the hands and feet
• migraine with or without aura, or loss of taste.
• problems with the eyes and vision, such as swollen and inflamed eyelids, watering eyes, blurred or double vision
• constant ringing in the ears
• high blood pressure
• decreased temperature and changes in the color of hands and feet or varicose veins
• nosebleeds, sore throat or runny nose
• swelling of the stomach lining
• feeling unwell, indigestion, dry mouth or flatulence
• excessive sweating
• silvery, scaly patches on the skin (psoriasis) or inflamed, swollen, red, itchy, sweaty or dry skin (eczema)
• acne or dry skin
• muscle weakness or muscle pain, joints and bones. Joints may also be stiff and swollen
• fatigue
• wounds
• blockage or damage to blood vessels, which may cause bleeding from the blood vessel, or in the most severe cases, damage to the surrounding tissue Very rare(may affect up to 1 in 10,000 people):
• inflammation of the skin (dermatitis)

Not known(frequency cannot be estimated based on the available data):

• increased levels of potassium in the blood
• problems with balance
• increased creatinine, urea, alkaline phosphatase, lactate dehydrogenase in the blood
• abnormal blood test results
• hair loss
• fever
• decrease in the number of proteins in the blood that carry oxygen (hemoglobin) and hematocrit (the percentage of blood volume that is occupied by red blood cells).

Other side effects reported following the use of ACE inhibitors other than trandolapril. It
is possible that you may experience these side effects. The frequency with which they may occur cannot
be estimated based on the available data and include:

• swelling of the lining of the intestine
• difficulty recognizing or remembering people, where you are or what time it is or memory problems
• difficulty breathing through the nose with facial pain (these may be signs of problems with the sinuses)
• swelling of the tongue
• increase in blood of some white blood cells or an increase in markers in the blood that indicate that the immune system may attack your body
• rash with measles-like patches.

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 Trandolapril Mylan Generics

• Keep this medicine out of the sight and reach of children.
• Store in the original packaging .
• Store at a temperature below 25ºC.
• Do not use this medicine after the expiry date which is stated on the pack after “Scad .”. 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. Package Contents and Other Information

What TrandolaprilMylan Genericscontains

• The active ingredient is trandolapril
• One capsule contains 0.5 mg, 2 mg of trandolapril
• The other ingredients are: lactose monohydrate (see section 2 “Trandolapril contains lactose); pregelatinized corn starch; microcrystalline cellulose; dimethicone; magnesium stearate; anhydrous colloidal silica. The capsule contains gelatin; titanium dioxide (E171) and erythrosine (E127).
• Furthermore, these dosages also contain the following:

0.5 mg: sunset yellow (E110) (see section 2 “Trandolapril contains the sunset yellow dye
”), quinoline yellow (E104)
2 mg: sunset yellow (E110) (see section 2 “Trandolapril contains the sunset yellow dye
”)

Description of the appearance of TrandolaprilMylan Generics and package contents
Each capsule contains a white powder
0.5 mg: oblong capsules of pale red – bright yellow color
2 mg: oblong capsules of light red – light red color

Contents:
Trandolapril Mylan Generics 0.5 mg, and 2 mg:
14, 20, 28, 30, 50, 56, 84, 90 and 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan, Italy

Manufacturer
Pharmathen International S.A., Sapes Industrial Park, Block 5, 69300 Rodopi, Greece
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan S.A.S, ZAC des Gaulnes, 10, Boulevard de Lattre de Tassigny, 69330 Meyzieu, France
Generics UK Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Denmark: Trandolapril Mylan, hard capsules 0.5 mg, 1 mg, 2 mg & 4 mg
France: Trandolapril Mylan 0.5 mg, 2 mg & 4 mg capsule
Italy: Trandolapril Mylan 0.5 mg & 2 mg
Portugal: Trandolapril Mylan 0.5 mg & 2 mg
Slovakia: Trandolapril Mylan 2 mg & 4 mg
United Kingdom: Trandolapril 0.5 mg, 1 mg, 2 mg & 4 mg Capsules