Ramipril Mylan Generics

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Ramipril Mylan Generics 2.5 mg tablets, 5 mg tablets, 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 other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT RAMIPRIL MYLAN GENERICS IS AND WHAT IT IS USED FOR

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

• Reducing the body's production of substances that can cause blood pressure to rise.
• Relaxing and widening your blood vessels.
• Helping your heart to pump blood around the body more easily.

Ramipril Mylan Generics can be used:

• To treat high blood pressure (hypertension).
• To reduce the risk of heart attack or stroke.
• To reduce the risk 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 following a heart attack (myocardial infarction) when associated with heart failure.

2. WHAT YOU SHOULD KNOW BEFORE TAKING RAMIPRIL MYLAN GENERICS

Do not take Ramipril Mylan Generics

• If you are allergic (hypersensitive) to ramipril, to other ACE inhibitor medicines, or to any of the other excipients of Ramipril Mylan Generics 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 experienced a serious 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 and swallowing.
• If you are undergoing dialysis or any other type of blood filtration. Depending on the equipment used, Ramipril Mylan Generics 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 must assess this.
• If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, such as in the throat).

Do not take Ramipril Mylan Generics if any of the above conditions apply to you. If
you are unsure, consult your doctor before taking Ramipril Mylan Generics.
Warnings and precautions
Talk to your doctor or pharmacist before taking RAMIPRIL MYLAN GENERICS:

• 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 from long-term use of oral diuretics, or after dialysis).
• If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitisation).
• If you are about to undergo anaesthesia, which may be administered during surgery or dental procedures. You may need to stop taking Ramipril Mylan Generics the day before; consult your doctor.
• If you have high levels of potassium in your blood (detected by a blood test).
• If you are taking medicines or have conditions that may cause low sodium levels in your blood. Your doctor may order regular blood tests, particularly to monitor sodium levels, especially if you are elderly.
• If you have a vascular collagen disease such as scleroderma or systemic lupus erythematosus.
• You must inform your doctor if you think you are pregnant (or could become pregnant). Ramipril Mylan Generics is not recommended during the first trimester of pregnancy and may cause severe 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 – for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• aliskiren.
• If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin, such as in the throat) may be increased:
• Racecadotril, a medicine used to treat diarrhoea;
• Medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus);
• Vildagliptin, a medicine used to treat diabetes.

Your doctor may monitor your kidney function, blood pressure, and levels of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also the section "Do not take Ramipril Mylan Generics"
Children and adolescents
The use of Ramipril Mylan Generics is not recommended in children and adolescents under
18 years of age, as the safety and efficacy of Ramipril Mylan Generics in children have not yet been established.
Other medicines and Ramipril Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This is because Ramipril Mylan Generics may affect the action of certain other medicines. Also, some medicines may affect the action of Ramipril Mylan Generics.
Inform your doctor if you are taking any of the following medicines. These medicines may interfere with Ramipril Mylan Generics, altering 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. Taking these
medicines together with Ramipril Mylan Generics may increase the likelihood of
undesirable effects:

• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indometacin, aspirin).
• Medicines for cancer treatment (chemotherapy).
• Diuretics such as furosemide.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics (such as spironolactone, triamterene, amiloride), angiotensin receptor blockers, and other medicines that may increase potassium levels in the blood (such as trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clotting).
• Steroid medicines used to treat inflammation, such as prednisolone.
• Allopurinol (used to lower uric acid levels in the blood).
• Procainamide (for heart rhythm problems).
• Vildagliptin (oral medicine to lower blood glucose). See section “Warnings and precautions”.
• Temsirolimus (used for cancer). See section “Warnings and precautions”.
• Sacubitril/valsartan, a medicine used to treat chronic heart failure in adults. See section “Do not take Ramipril Mylan Generics”.
• Racecadotril (used to treat diarrhoea). See section “Warnings and precautions”.
• Medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.

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

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

Your doctor may consider it necessary to adjust the dose and/or take additional precautions:

• If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "Do not take Ramipril Mylan Generics" and "Warnings and precautions").

If any of the above conditions apply (or if you are unsure), consult your doctor before
taking Ramipril Mylan Generics.
Taking Ramipril Mylan Generics with food and alcohol

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

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant (or could become pregnant).
You must not take Ramipril Mylan Generics during the first 12 weeks of pregnancy and must
not take it at all after the 13th week, as it may harm the unborn child.
If you become pregnant while taking Ramipril Mylan Generics, inform your doctor
immediately. Before planning a pregnancy, you should switch to another medicine.
Breast-feeding
You must not take Ramipril Mylan Generics if you are breast-feeding.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
You may experience dizziness while taking Ramipril Mylan Generics. This is more likely when you have just started taking Ramipril Mylan Generics or have recently increased the dose. If this occurs, do not drive or operate tools or machinery.
Important information about some excipients of Ramipril Mylan Generics
Ramipril Mylan Generics contains a milk sugar (lactose).
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 MYLAN GENERICS

Always take Ramipril Mylan Generics exactly as prescribed by your doctor.
If you are unsure, ask your doctor or pharmacist for advice.

Taking this medicine

• Take the medicine orally 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 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 Mylan Generics.

Treatment 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 prevent worsening of kidney problems

• You may initially be given 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 daily dose into two administrations.

Elderly patients
Your doctor will reduce the initial dose and adjust treatment more gradually.

If you take more Ramipril Mylan Generics than you should
Contact your doctor or go to the nearest hospital emergency department immediately. Do not drive yourself to the hospital; have someone accompany 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 Mylan Generics

• 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 further questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Ramipril Mylan Generics can cause adverse reactions, although
not everyone experiences them.
Stop taking Ramipril Mylan Generics and contact your doctor immediately
if you notice any of the following serious adverse reactions – you may
need urgent medical treatment:

• Swelling of the face, lips, or throat causing difficulty in swallowing or breathing, as well as itching or skin rash. This could be a sign of a serious allergic reaction to Ramipril Mylan Generics.
• Severe skin reactions including rash, mouth ulcers, 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).

Contact your doctor immediately if you experience:

• Rapid heartbeat, irregular or forceful 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.

• Easy 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, fever, feeling tired, weakness, 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, fatigue, loss of appetite, stomach pain, nausea, 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 adverse reactions 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 patients treated)

• Headache or feeling of tiredness.
• Dizziness. This is more likely to occur when treatment with Ramipril Mylan Generics 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 vomiting.
• 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 patients treated)

• Balance problems (dizziness).
• Itching and unusual skin sensations such as numbness, tingling, burning, prickling, or scraping feelings (paresthesia).
• Loss or change in taste.
• Sleep problems.
• Depressed mood, anxiety, increased nervousness or irritability.
• Stuffy nose, breathing difficulties, 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.
• Loss of or reduced appetite (anorexia).
• Fast 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 sex drive in men and women.
• Increase in the number of white blood cells (eosinophilia) detected during blood tests.
• Changes in liver, pancreas, or kidney function as shown by blood tests.

Rare (affects less than 1 in 1,000 patients treated)

• Feeling faint or confused.
• Swollen and red tongue.
• Severe peeling or shedding of the skin, itching, rash characterized by pustules.
• Nail problems (such as nail loss or separation of the nail from its bed).
• Skin rash or bruising.
• Skin spots and cold extremities.
• Red, swollen, watery, or itchy eyes.
• Hearing problems and ringing in the ears.
• Feeling of weakness.
• Decrease in the number of red blood cells, white blood cells, platelets, or haemoglobin concentration, as shown by blood tests.

Very rare (affects less than 1 in 10,000 patients treated)

• Increased sensitivity to sunlight.

Not known

• Concentrated (dark-coloured) urine, feeling unwell, muscle cramps, confusion, and seizures which may be due to inappropriate production of ADH (anti-diuretic hormone). If you experience these symptoms, contact your doctor promptly.

Other adverse reactions 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.
• Fingers of hands and feet changing colour when exposed to cold, and tingling or pain upon warming (Raynaud's phenomenon).
• Breast enlargement in men.
• Slowed or altered reactions.
• Burning sensation.
• Changes in the perception of smells.
• Hair loss.

If you notice any adverse reaction not listed in this leaflet,
inform your doctor or pharmacist.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this
leaflet, contact your doctor or pharmacist. You may also report adverse reactions
directly via the national reporting system at the following website:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting adverse reactions, you can help provide more information on
the safety of this medicine.

5. HOW TO STORE RAMIPRIL MYLAN GENERICS

Keep Ramipril Mylan Generics out of the sight and reach of children.
Do not store above 25°C.
Do not use Ramipril Mylan Generics after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Ramipril Mylan Generics contains
The active substance is ramipril.
The excipients are: sodium hydrogen carbonate, monohydrate lactose, sodium croscarmellose,
pregelatinized starch, sodium stearyl fumarate, yellow iron oxide (E172) (only in 2.5 mg and 5 mg tablets),
red iron oxide (E172) (only in 5 mg tablets).

Description of the appearance of Ramipril Mylan Generics and pack contents
Pack sizes of 10, 14, 20, 28, 30, 42, 50, 98 and 100 tablets in Al/Al blisters.
Not all pack sizes may be marketed.

Tablet appearance:
2.5 mg: yellow, capsule-shaped, uncoated, flat tablets, 10.0 x 5.0 mm, with a break line on one side and engraved "R2" on both sides.
5 mg: pink, capsule-shaped, uncoated, flat tablets, 8.8 x 4.4 mm, with a break line on one side and engraved "R3" on both sides.
10 mg: white to off-white, capsule-shaped, uncoated, flat tablets, 11.0 x 5.5 mm, with a break line on one side and engraved "R4" on both sides.

Marketing Authorization Holder:
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan
Italy

Responsible manufacturers for batch release:
Actavis Ltd.
BLB016, Bulebel Industrial Estate,
Zejtun
ZTN 3000
Malta

Actavis hf.
Reykjavikurvegur 76-78
220 Hafnarfjörður,
Iceland

This leaflet was last approved on: