Ramipril Pensà

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ramipril Pensa 2.5 mg tablets, 5 mg tablets, 10 mg tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine.

• 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 personally. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:
1. What Ramipril Pensa tablets are and what they are used for
2. Before you take Ramipril Pensa
3. How to take Ramipril Pensa
4. Possible side effects
5. How to store Ramipril Pensa
6. Further information

1. WHAT RAMIPRIL PENSA IS AND WHAT IT IS USED FOR

Ramipril Pensa contains a medicine called ramipril which belongs to a group of
medicines known as ACE inhibitors (Angiotensin-Converting Enzyme inhibitors).
Ramipril Pensa 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 pump blood around the body more easily.

Ramipril can be used:

• To treat high blood pressure (hypertension)
• 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 volume of blood to the rest of the body (heart failure)
• As treatment after a heart attack (myocardial infarction), if associated with heart failure.

2. BEFORE TAKING RAMIPRIL PENSA

Do not take Ramipril Pensa

• If you are allergic (hypersensitive) to ramipril, to other ACE inhibitors, or to any of the excipients of Ramipril Pensa 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 severe allergic reaction called "angioedema." Symptoms may 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 undergoing dialysis or any other type of blood filtration. Depending on the equipment used, Ramipril Pensa 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 six months of pregnancy (see section below "Pregnancy").
• If your blood pressure is excessively low or unstable. Your doctor will need to assess this.

Do not take Ramipril Pensa if any of the above conditions apply. If you are unsure, consult your doctor before taking Ramipril Pensa.

Take special care with Ramipril Pensa

Check with your doctor or pharmacist before taking Ramipril Pensa:

• 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, diarrhea, excessive sweating, or as a result of a low-salt diet, long-term use of oral diuretics, or after undergoing dialysis).
• If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitization).
• If you are about to undergo anesthesia. This may be administered during surgery or dental procedures. You may need to stop taking Ramipril Pensa the day before; consult your doctor.
• If you have high levels of potassium in your blood (as shown by a blood test).
• If you have a vascular collagen disorder such as scleroderma or systemic lupus erythematosus.
• You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Ramipril Pensa is not recommended during the first three months of pregnancy and may cause severe harm to the unborn baby if taken after the third month of pregnancy (see section below "Pregnancy and breastfeeding").

Children
The use of Ramipril Pensa is not recommended in children and adolescents under 18 years of age, as the safety and efficacy of Ramipril Pensa in children have not yet been established.

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

Taking Ramipril Pensa with other medicines

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those without a prescription (including herbal medicines). This is because Ramipril Pensa may affect the action of certain other medicines, and some medicines may affect the action of Ramipril Pensa.

Inform your doctor if you are taking any of the following medicines. These medicines may interfere with Ramipril Pensa and alter its effect:

• Medicines used to relieve pain and inflammation (e.g., Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indomethacin, 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 Ramipril Pensa may increase the risk of side effects:

• Medicines used to relieve pain and inflammation (e.g., Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indometacine, aspirin).
• Cancer medicines (chemotherapy).
• Medicines to prevent organ rejection after transplant, such as cyclosporine.
• Diuretics such as furosemide.
• Medicines that may increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, and heparin (used to make blood less likely to clot).
• Steroid medicines used to treat inflammation, such as prednisolone.
• Allopurinol (used to lower uric acid levels in the blood).
• Procainamide (used for heart rhythm problems).

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

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

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

Taking Ramipril Pensa with food and alcohol

• Drinking alcoholic beverages while taking Ramipril Pensa may cause dizziness or lightheadedness. Discuss with your doctor how much alcohol you may drink while taking Ramipril Pensa, as blood pressure-lowering medicines and alcohol may have additive effects.
• Ramipril Pensa may be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). You should not take Ramipril Pensa during the first 12 weeks of pregnancy and must not take it at all after the 13th week, as its use during pregnancy may harm the unborn baby. Inform your doctor immediately if you become pregnant while taking Ramipril Pensa. Before planning a pregnancy, you should switch to an appropriate alternative treatment.

Breast-feeding
You should not take Ramipril Pensa if you are breast-feeding.

Ask your doctor or pharmacist before taking any medicine.

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

Important information about some excipients of Ramipril Pensa
Ramipril Pensa contains a milk sugar (lactose).
Contact your doctor before using this medicine if you have been told that you are intolerant to certain sugars.

3. HOW TO TAKE RAMIPRIL PENSA

Always take Ramipril Pensa exactly as instructed by your doctor.
You should consult your doctor or pharmacist if you are unsure.
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.

Dosage
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 Pensa.
  Treatment to reduce or prevent 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 as needed.

• 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 as needed.

• The maximum dose is 10 mg per day. It is preferable to divide this dose into two daily 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 as needed.

• The usual dose is 10 mg per day. It is preferable to divide this dose into two daily administrations.

Elderly patients
Your doctor will reduce the initial dose and adjust treatment more slowly.
If you take more Ramipril Pensa than you should
Contact your doctor or go to the nearest hospital emergency department immediately.
Do not drive yourself—have someone accompany you or call an ambulance.
Bring the medicine pack with you so the doctor knows what you have taken.
If you forget to take Ramipril Pensa

• 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, Ramipril Pensa can cause side effects, although not everybody gets them.
Stop taking Ramipril Pensa 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 in swallowing or breathing, as well as itching or skin rash. This could be a sign of a serious allergic reaction to Ramipril Pensa.
• Serious skin reactions including rash, mouth ulcers, worsening of pre-existing skin disease, 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 or 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, 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 and fever, feeling tired, weak, dizzy or pale skin. 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 patients taking the medicine)

• Headache or feeling tired
• Dizziness. This is more likely when treatment with Ramipril Pensa has just started or the dose has recently been increased
• Weakness, hypotension (unusually low blood pressure), especially when standing up or getting up quickly
• Dry, persistent cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath
• Stomach or intestinal pain, diarrhoea, indigestion, feeling unwell or malaise
• 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 taking the medicine)

• Balance problems (dizziness)
• Itching and unusual skin sensations such as numbness, tingling, burning, prickling or scratching (paraesthesia)
• Loss or change in taste
• Sleep disturbances
• 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 appetite 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 in blood tests
• Changes in liver, pancreas or kidney function shown by blood tests.

Rare (affects less than 1 in 1000 patients taking the medicine)

• 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
• Skin spots and cold extremities
• Red, swollen, watery or itchy eyes
• Hearing problems and ringing in the ears (tinnitus)
• Feeling weak
• Decrease in the number of red blood cells, white blood cells and platelets or haemoglobin concentration, shown by blood tests.

Very rare (affects less than 1 in 10,000 patients taking the medicine)

• Increased sensitivity to sunlight.

Other side effects observed:
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 painful when warmed (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 side effect not listed in this leaflet, inform your doctor or pharmacist.

5. HOW TO STORE RAMIPRIL PENSA

Keep out of the reach and sight of children.
Do not store above 25°C.
Do not use Ramipril Pensa after the expiry date stated on the packaging after
EXP. 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. OTHER INFORMATION

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

Description of the appearance of Ramipril Pensa tablets and contents of the pack
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.)
Appearance of the tablets:
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 the 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 the 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 the sides.

Marketing Authorization Holder:
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milano, Italy

Manufacturer:
Actavis Ltd.
B16, Bulebel Industrial Estate,
Zejtun
ZTN 08
Malta
Actavis hf.
Reykjavikurvegur 76-78
220 Hafnarfjörður,
Iceland

This medicinal product is authorized in the EEA Member States under the following names:
Italy: Ramipril Pensa

This leaflet was last approved in: August 2012
This patient information leaflet does not contain all information about this medicine. If you have further questions or are unsure about anything, please consult your doctor or pharmacist.