Package Insert: Information for the Patient

Ramipril ratiopharm 2.5 mg Tablets

Ramipril ratiopharm 5 mg Tablets

Ramipril ratiopharm 10 mg Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Ramipril ratiopharm and what is it used for

2. What you need to know before starting to take Ramipril ratiopharm

3. How to take Ramipril ratiopharm

4. Possible side effects

5. Storage of Ramipril ratiopharm

6. Contents of the package and additional information

Ramipril ratiopharm contains a medicine called ramipril. This belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors.

Ramipril ratiopharm works as follows:

• By reducing the body's production of substances that could increase its blood pressure
• By relaxing and widening its blood vessels
• By making it easier for its heart to pump blood throughout its body.

Ramipril ratiopharm may be used:

Do not take Ramipril ratiopharm:

• If you are allergic (hypersensitive) to ramipril, any other ACE inhibitor, or any of the other components of Ramipril ratiopharm (listed in section 6).

The symptoms of an allergic reaction may include skin rash, difficulty swallowing or breathing, swelling of your lips, face, throat, or tongue.

• If you have ever had a severe allergic reaction called “angioedema”. The symptoms include itching, urticaria, red patches on your hands, feet, and throat, swelling of your throat and tongue, swelling around your eyes and lips, difficulty breathing and swallowing.
• If you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, Ramipril ratiopharm may not be suitable for you.
• If you have kidney problems when your blood flow to your kidneys is reduced (renal artery stenosis).
• During the last 6 months of pregnancy (see section “Pregnancy and breastfeeding”)
• If your blood pressure is abnormally low or unstable. Your doctor will need to assess this.
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medication that contains aliskiren.
• If you have taken or are currently taking sacubitril/valsartan, a medication used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high.

Do not take Ramipril ratiopharm if you have any of the above conditions. If you are unsure, speak with your doctor before taking Ramipril ratiopharm.

Warnings and precautions

Check with your doctor or pharmacist before taking your medication:

• If you have heart, liver, or kidney problems.
• If you have lost a lot of minerals or fluids (due to vomiting, diarrhea, excessive sweating, being on a low-salt diet, taking diuretics for a long time, or being on dialysis).

If you are undergoing treatment to reduce your allergy to bee or wasp stings (desensitization).

• If you are taking any of the following medications used to treat high blood pressure (hypertension):

• An angiotensin II receptor antagonist (ARA) (also known as “sartanes” – for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• Aliskiren.

Your doctor may need to monitor your kidney function, blood pressure, and blood electrolyte levels (such as potassium) at regular intervals.

See also the information under the heading “Do not take Ramipril ratiopharm”

• If you are to receive an anesthetic. This may be due to surgery or any dental treatment. You may need to stop taking your treatment a day before; consult your doctor.

• If you have high levels of potassium in your blood (detected in blood test results).
• If you are taking medications or have conditions that decrease sodium levels in your blood. Your doctor may perform regular blood tests, particularly to monitor sodium levels in your blood, especially in older patients.

• If you are of black race, you may have a higher risk of angioedema and this medication may be less effective in reducing blood pressure in patients who are not of black race.

• If you are taking any of the following medications, the risk of angioedema, a severe allergic reaction (rapid swelling under the skin in certain areas such as the throat), may increase:
• Racecadotril, a medication used to treat diarrhea.
• Medications used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medication used to treat type 2 diabetes.

• If you have a vascular collagen disease such as scleroderma or systemic lupus erythematosus.
• Inform your doctor if you are pregnant (or if you suspect you may be). Ramipril ratiopharm is not recommended in the first 3 months of pregnancy, and may cause serious harm to your baby after 3 months of pregnancy (see section “Pregnancy and breastfeeding”)

Children and adolescents

Ramipril ratiopharm is not recommended for use in children and adolescents under 18 years of age because its safety and efficacy have not yet been established in children.

If you have any of the above conditions (or are unsure), speak with your doctor before taking Ramipril ratiopharm.

Other medications and Ramipril ratiopharm

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.This is because Ramipril ratiopharm may affect how some other medications work. Similarly, some medications may affect how Ramipril ratiopharm works.

Inform your doctor if you have taken or are taking any of the following medications, which may make Ramipril ratiopharm work less effectively:

• Medications used to relieve pain and inflammation (e.g., nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and aspirin).
• Medications 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.

Inform your doctor if you are taking any of the following medications. These may increase the risk of side effects if taken with Ramipril ratiopharm:

• Sacubitril/valsartan – used to treat a type of long-term (chronic) heart failure in adults (see section 2 “Do not take Ramipril ratiopharm”
• Medications used to relieve pain and inflammation (e.g., nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and aspirin).
• Cancer medications (chemotherapy)

• Diuretics such as furosemide.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medications that may increase potassium levels in your blood (e.g., trimethoprim and co-trimoxazole for bacterial infections; ciclosporin, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medication used to thin your blood to prevent clots).

• Steroid medications for inflammation such as prednisolone.
• Alopurinol (used to reduce uric acid levels in your blood)

• Procainamide (for heart rhythm problems).
• Temsirolimus (for cancer)
• Sirolimus, everolimus (for organ transplant rejection)
• Vildagliptin (used to treat type 2 diabetes)
• Racecadotril (used to treat diarrhea)

Your doctor may need to adjust your dose and/or take other precautions:

• if you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Ramipril ratiopharm” and “Warnings and precautions”).

Inform your doctor if you are taking any of the following medications. These may be affected by Ramipril ratiopharm:

• Medications used to treat diabetes such as medications to lower blood glucose and insulin. Ramipril ratiopharm may reduce your blood sugar levels. Monitor your blood sugar levels carefully while taking Ramipril ratiopharm.
• Lithium (for mental health problems). Ramipril ratiopharm may increase your lithium levels. Your doctor will monitor your lithium levels in your blood carefully.

If you have any of the above conditions (or are unsure), speak with your doctor before taking Ramipril ratiopharm.

Taking Ramipril ratiopharm with food, drinks, and alcohol

• Drinking alcohol with Ramipril ratiopharm may make you feel dizzy or disoriented. If you are concerned about how much you can drink while taking Ramipril ratiopharm, speak with your doctor, as medications used to lower blood pressure and alcohol may have additive effects.
• Ramipril ratiopharm can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant (or if you suspect you may be). Do not take ramipril in the first 12 weeks of pregnancy and do not take it at all after week 13, as its use during pregnancy may cause harm to your baby. If you become pregnant while taking ramipril, inform your doctor immediately. A suitable alternative treatment should be changed before planning a pregnancy.

Breastfeeding

You must not take ramipril if you are breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery:

You may feel dizzy while taking Ramipril ratiopharm, which is more likely to occur when starting Ramipril ratiopharm or starting a higher dose. If this occurs, do not drive or operate tools or machinery

Ramipril ratiopharm contains lactose.

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Ramipril ratiopharm contains sodium

This medication contains less than 1 mmol of sodium (23 mg); it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much medication to take

Hypertension treatment

• The recommended starting dose is 1.25 mg or 2.5 mg once a day
• Your doctor will adjust the amount you should take to control your blood pressure
• The maximum daily dose is 10 mg once a day.
• If you are already taking diuretics, your doctor may interrupt or reduce the amount of diuretic you were taking previously before starting treatment with ramipril.

To reduce the risk of suffering a heart attack or stroke

• The recommended starting dose is 2.5 mg once a day
• Your doctor may decide to increase the amount you take
• The usual dose is 10 mg once a day

Treatment to reduce or delay the worsening of kidney problems

• You can 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 for heart failure

• The recommended starting dose is 1.25 mg once a day
• Your doctor will adjust the amount you are taking
• The maximum daily dose is 10 mg. It is preferable to administer it twice a day.

Treatment after having had a heart attack

• The recommended starting dose is 1.25 mg once a day to 2.5 mg twice a day.
• Your doctor will adjust the amount you are taking
• The usual dose is 10 mg a day. It is preferable to administer it twice a day.

Older patients

Your doctor will reduce the initial dose and adjust your treatment more slowly.

Taking this medication

• Take this medication orally at the same time every day.
• Swallow the Ramipril ratiopharm tablets whole, with liquid.
• Do not crush or chew the tablets.

If you take more Ramipril ratiopharm than you should

Consult your doctor immediately or go to the nearest hospital emergency room, accompanied by this leaflet. Do not drive to the hospital, ask someone to take you or call an ambulance. Bring the medication packaging with you. This way your doctor will know what you have taken.

You can also call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount taken.

If you forgot to take Ramipril ratiopharm

• If you forgot to take a dose, take your regular dose when it's time for the next one.
• Do not take a double dose to make up for the missed doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Ramipril ratiopharm can cause side effects, although not everyone will experience them.

Stop taking Ramipril ratiopharm and seek immediate medical attention if you notice any of the following severe side effects, which may require urgent medical treatment:

• Swelling of the face, lips, or throat that may make it difficult to swallow or breathe, as well as itching and hives. This can be a sign of a severe allergic reaction to Ramipril ratiopharm.
• Severe skin reactions, including rashes, ulcers in the mouth, worsening of an existing skin condition, redness, blisters, or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme)

Inform your doctor immediately if you experience:

Other side effects include:

Inform your doctor if any of the following symptoms worsen or last for more than a few days.

Frequent(may affect up to 1 in 10 patients)

Rare(may affect up to 1 in 100 patients)

• Balance problems (dizziness)
• Itching and abnormal sensations in the skin, such as numbness, tingling, pinpricks, burning, or chills
• Loss or changes in the taste of things
• Difficulty sleeping
• Feeling sad, anxious, more nervous than normal, or tired
• Nasal congestion, difficulty breathing, or worsening of asthma.
• Abdominal swelling known as "intestinal angioedema" that presents symptoms such as abdominal pain, vomiting, and diarrhea
• Heartburn, constipation, or dry mouth
• Urinating more frequently during the day
• Acute renal failure, renal failure
• Sweating more than normal
• Loss or decrease in appetite (anorexia)
• Increased or irregular heartbeats
• Swelling of arms and legs. This may be a sign that your body is retaining more water than normal
• Redness
• Blurred vision
• Joint pain
• Fever
• Sexual dysfunction in men, decreased libido in men or women
• Increased number of certain white blood cells (eosinophilia) found during a blood test.
• Blood tests show changes in how your liver, pancreas, or kidneys are functioning

Very rare(may affect up to 1 in 10,000 patients)

• Feeling insecure or confused
• Redness and swelling of the tongue.
• Severe scaling or peeling of the skin, hives, itching,
• Problems with the nails (e.g. loss or separation of a nail from its bed)
• Hives or bruises on the skin.
• Redness, cold extremities
• Redness, itching, swelling, and tearing of the eyes
• Changes in hearing and ringing in the ears
• Feeling weak
• Blood tests show a decrease in the number of red blood cells or platelets or in the amount of hemoglobin.

Very rare (may affect up to 1in 10,000 patients)

Being more sensitive to the sun than normal.

Not known:cannot be estimated from available data

• Dark-colored urine, discomfort, muscle cramps, confusion, and seizures that may be due to inadequate secretion of ADH (antidiuretic hormone). If you have these symptoms, consult your doctor as soon as possible.
• Difficulty concentrating
• Mouth pain
• Blood tests may show elevated levels of antibodies
• Blood tests show very few blood cells
• Blood tests show lower-than-normal sodium levels
• Fingers on the hands and feet change color when it's cold and feel numbness or pain when warmed (Raynaud's phenomenon)
• Enlargement of the chest in men
• Slowness or difficulty reacting
• Feeling of burning
• Change in the smell of things.
• Loss of hair.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it's a possible side effect that doesn't appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister and packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

Composition of Ramipril ratiopharm 2,5 mg

• The active ingredient is ramipril. Each tablet contains 2.5 mg of ramipril.
• The other components (excipients) are: lactose monohydrate, sodium hydrogen carbonate, sodium croscarmellose, pregelatinized cornstarch, sodium stearate fumarate, and yellow iron oxide (E-172).

Composition of Ramipril ratiopharm 5 mg

• The active ingredient is ramipril. Each tablet contains 5 mg of ramipril.
• The other components (excipients) are: lactose monohydrate, sodium hydrogen carbonate, sodium croscarmellose, pregelatinized cornstarch, sodium stearate fumarate, yellow iron oxide (E-172), and red iron oxide (E-172).

Composition of Ramipril ratiopharm 10 mg

• The active ingredient is ramipril. Each tablet contains 10 mg of ramipril.
• The other components (excipients) are: lactose monohydrate, sodium hydrogen carbonate, sodium croscarmellose, pregelatinized cornstarch, and sodium stearate fumarate.

Appearance of the product and contents of the package

Ramipril ratiopharm 2,5 mg tablets

Yellow-red, round, biconvex tablets with a breaking mark on one side and a diameter of 8.0 mm.

Ramipril ratiopharm 5 mg tablets

Rose-colored, round, biconvex tablets with a breaking mark on one side and a diameter of 6.5 mm.

Ramipril ratiopharm 10 mg tablets

White or off-white, round, biconvex tablets with a breaking mark on one side and a diameter of 9.0 mm.

Packages containing 10, 14, 20, 28, 30, 42, 50, 56, 98, and 100 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st Floor

28108 Alcobendas, Madrid

Responsible for manufacturing

Merckle GmbH

Ludwig-Merckle-Strasse, 3

89143 Blaubeuren (Germany)

or

ACTAVIS LIMITED.BLB016

Bulebel Industrial Estate

Zejtun (Malta)

This medicine is authorized in the Member States of the European Economic Area with the following names:

Ramipril 2,5 mg tablets

Portugal: Ramipril ratiopharm 2,5 mg tablets

Spain: Ramipril ratiopharm 2,5 mg tablets

Ramipril 5 mg tablets

Portugal: Ramipril ratiopharm 5 mg tablets

Spain: Ramipril ratiopharm 5 mg tablets

Ramipril 10 mg tablets

Portugal: Ramipril ratiopharm 10 mg tablets

Spain: Ramipril ratiopharm 10 mg tablets

Last review date of this leaflet:March 2023

“Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)”