RAMIPRIL 2.5 мг Коированные таблетки

Содержание инструкции

1. WHAT IS RAMIPRIL PENSA AND WHAT IS IT USED FOR
2. BEFORE TAKING RAMIPRIL PENSA
3. HOW TO TAKE RAMIPRIL PENSA
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE RAMIPRIL PENSA
6. OTHER INFORMATION

Ramipril Pensa 2.5 mg tablets
Ramipril Pensa 5 mg tablets
Ramipril Pensa 10 mg tablets
Generic medicine
Read this leaflet carefully before 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. Indeed, this medicine may be dangerous for other individuals, even if their symptoms are the same as yours.
• If any of the side effects become serious, or if you notice any side effect not listed in this leaflet, tell 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

6Further information

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

Ramipril Pensa contains a medicine called ramipril which belongs to the group of
drugs called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).
Ramipril Pensa works by:

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

Ramipril can be used:

• To treat high blood pressure (hypertension)
• To reduce the risk or delay the worsening of kidney problems (whether or not diabetes is present)
• To treat its heart when it cannot pump a sufficient volume of blood around 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 can include skin rashes, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue
• If you have had a severe allergic reaction called “angioedema”. These signs include itching, skin rash (urticaria), red spots on the hands, feet and in the throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing
• If you are on dialysis or undergoing any other type of blood filtration. Depending on the machinery 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. The doctor will need to make this assessment.

Do not take Ramipril Pensa if any of the above conditions apply to you. If you are not
sure, ask 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 a lot of salts or body fluids (due to an illness such as vomiting, diarrhea, excessive sweating, or following a low-salt diet, or after taking oral diuretics for a long period of time or having undergone 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 for surgery or dental work. It may be necessary to stop treatment with Ramipril Pensa the day before, ask your doctor for advice
• If you have a high amount of potassium in your blood (shown by a blood test)
• If you have a connective tissue disease such as scleroderma or systemic lupus erythematosus
• You must inform your doctor if you think you may be pregnant (or if there is a possibility of starting a pregnancy). Ramipril Pensa is not recommended in the first three months of pregnancy, and can cause serious harm to the baby if taken after the three months of pregnancy (see the section below “Pregnancy and breastfeeding”).

Children
The use of Ramipril Pensa is not recommended in children and adolescents under the age of 18
years because the safety and efficacy of Ramipril Pensa in children has not been
established.
If any of the above conditions apply to you (or you are not sure), ask your doctor before
taking Ramipril Pensa.

Taking Ramipril Pensa with other medicines
Tell 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 can affect the mechanism of action
of some other medicines. Also some medicines can affect the mechanism
of action of Ramipril Pensa.
Tell your doctor if you are taking any of the following medicines. These medicines can
interfere with Ramipril Pensa 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, norepinephrine or adrenaline. The 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 Ramipril Pensa, 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)
• Medicines to prevent organ rejection after transplantation such as cyclosporine
• Diuretics such as furosemide
• Medicines that can increase the amount of potassium in the blood such as spironolactone, triamterene, amiloride, potassium salts and heparin (used to make the blood more fluid)
• Steroid medicines for the treatment of inflammation such as prednisolone
• Allopurinol (used to lower uric acid levels in the blood)
• Procainamide (for heart rhythm problems).

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

• Diabetes medicines such as oral hypoglycemic agents and insulin. Ramipril Pensa can lower blood sugar levels. Carefully check your blood sugar levels when taking Ramipril Pensa.
• Lithium (for psychiatric problems). Ramipril Pensa can increase the amount of lithium in the blood. The level of lithium in your blood must be carefully monitored by your doctor. If any of the above conditions apply to you (or you are not sure), ask your doctor before taking Ramipril Pensa.

Taking Ramipril Pensa with food and alcohol

• Drinking alcoholic beverages together with Ramipril Pensa can cause dizziness or lightheadedness. If you want to know how much alcohol to drink when taking Ramipril Pensa, discuss this with your doctor, as medicines used to lower blood pressure and alcohol can have additive effects.
• Taking Ramipril Pensa can be done with or without food.

Pregnancy and breastfeeding

Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility
of starting a pregnancy). You should not take Ramipril Pensa in the first 12
weeks of pregnancy, and you must not take it at all after the thirteenth week as
use during pregnancy could be harmful to the baby. Immediately inform
your doctor if you become pregnant while being treated with Ramipril Pensa. Prior
to a planned pregnancy, you should switch to an appropriate alternative treatment.

Breastfeeding
You should not take Ramipril Pensa if you are breastfeeding.
Ask your doctor or pharmacist before taking any medicine.

Driving and using machines
You may feel dizzy while taking Ramipril Pensa. This is more
likely when you have just started taking Ramipril Pensa or have just increased the
dose. If this happens, do not drive or use tools or machinery.

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

3. HOW TO TAKE RAMIPRIL PENSA

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

Taking this medicine

• Take the medicine by mouth at the same time of day, every 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 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 Ramipril Pensa. Treatment to reduce or prevent worsening of kidney problems
• You may be given to start with 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 usual 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 usual 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
Your doctor will reduce the initial dose and adjust the treatment more slowly.

If you take more Ramipril Pensa than you should
Tell 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
medicine packaging. This is because the doctor needs to know what you have taken.

If you forget to take Ramipril Pensa

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

If you have any further questions about the use of this medicine, ask 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 the
appearance of any serious side effect - 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 Ramipril Pensa.
• 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:

• Increased heart rate, 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 formation of bruises, 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, dizziness or pale skin. These can be signs of circulatory or bone marrow problems
• Severe abdominal pain that can 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(affect less than 1 in 10 patients undergoing treatment)

• Headache or feeling tired
• Feeling dizzy. This is more likely to happen when treatment with Ramipril Pensa is just started or you have just increased the dose
• Weakness, 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 unwell or generally unwell
• Rash with or without swelling
• Chest pain
• Muscle cramps or pain
• Blood tests show a higher than normal level of potassium.

Uncommon(affect less than 1 in 100 patients undergoing treatment)

• Problems with balance (dizziness)
• Itching and unusual skin sensations such as numbness, tingling, burning, prickling or chafing (paresthesia)
• Loss or change of taste
• Sleep problems
• Depressed mood, anxiety, increased nervousness than usual or irritability
• Blocked nose, difficulty breathing or worsening of asthma
• Swelling of the intestine 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
• Swollen arms and legs. 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 (eosinophilia) found during blood tests
• Changes in liver, pancreas or kidney function highlighted by blood tests.

Rare(affect less than 1 in 1000 patients undergoing treatment)

• Feeling faint or confused
• 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 disorders and ringing in the ears
• Feeling weak
• 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(affect less than 1 in 10000 patients undergoing treatment)

• 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 of the hands and feet 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.

If you get any side effects not listed in this leaflet, tell your doctor or pharmacist.

5. HOW TO STORE RAMIPRIL PENSA

Keep out of the reach and sight of children .
Do not store at a temperature above 25°C.
Do not use Ramipril Pensa after the expiry date which is 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 ingredient is ramipril.
The excipients are: sodium hydrogen carbonate, lactose monohydrate, sodium croscarmellose,
pregelatinized starch, sodium stearyl fumarate, yellow iron oxide (E172) (only in the
2.5 and 5mg tablets), red iron oxide (E172) (only in the 5mg tablets).

Description of the appearance of Ramipril Pensa tablets and contents of the pack
Packs 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 fracture line on one
side and “R2” imprinted on the sides.
5 mg: pink, capsule-shaped, uncoated, flat tablets, 8.8 x 4.4 mm, with a fracture line on one
side and “R3” imprinted on the sides.
10 mg: white to off-white, capsule-shaped, uncoated, flat tablets, 11.0 x 5.5
mm with a fracture line on one side and “R4” imprinted on the sides.

Marketing Authorisation Holder:
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milan

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

This medicinal product is authorised in the Member States of the EEA under the following
denominations:
Italy: Ramipril Pensa

This leaflet was last revised in: August 2012
questions or are not sure about something, ask your doctor or pharmacist.