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Document: Ramipril STADA tablet ENG PL change

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• Ramipril STADA tablet ENG PL

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Package leaflet: Information for the user

Ramipril STADA 2.5 mg, 5 mg, 10 mg tablets

ramipril

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

2. What you need to know before you take Ramipril STADA

3. How to take Ramipril STADA

4. Possible side effects

5. How to store Ramipril STADA

6. Contents of the pack and other information

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

Ramipril STADA contains a medicine called ramipril. This belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).

Ramipril STADA works by:

• Decreasing your body’s production of substances that could raise your blood pressure

• Making your blood vessels relax and widen

• Making it easier for your heart to pump blood around your body.

Ramipril STADA can be used:

• To treat high blood pressure (hypertension)

• To reduce the risk of you having a heart attack or stroke

• To reduce the risk or delay the worsening of kidney problems (whether or not you have diabetes)

• To treat your heart when it cannot pump enough blood to the rest of your body (heart failure)

• As treatment following heart attack (myocardial infarction) complicated with heart failure.

2. What you need to know before you take Ramipril STADA

DO NOT take Ramipril STADA

Signs of an allergic reaction may include a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

• If you have ever had a serious allergic reaction called “angioedema”. The signs include itching, hives (urticaria), red marks 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 having dialysis or any other type of blood filtration. Depending on the machine that is used, Ramipril STADA may not be suitable for you

• If you have kidney problems where the blood supply to your kidney is reduced (renal artery stenosis)

• During the last 6 months of pregnancy (see section below on “Pregnancy and breast-feeding”)

• If your blood pressure is abnormally low or unstable. Your doctor will need to make this assessment.

• If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

Do not take Ramipril STADA if any of the above applies to you. If you are not sure, talk to your doctor before taking Ramipril STADA.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ramipril STADA:

• If you have heart, liver or kidney problems

• If you have lost a lot of body salts or fluids (through being sick (vomiting), having diarrhoea, sweating more than usual, being on a low salt diet, taking diuretics (water tablets) for a long time or having had dialysis)

• If you are going to have treatment to reduce your allergy to bee or wasp stings (desensitisation)

• If you are going to receive an anaesthetic. This may be given for an operation or any dental work. You may need to stop your Ramipril STADA treatment one day beforehand; ask your doctor for advice

• If you have high amounts of potassium in your blood (shown in blood test results)

• If you are taking medicines called mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus) or vildagliptin as they may increase the risk of angioedema, a serious allergic reaction.

• If you have collagen vascular disease such as scleroderma or systemic lupus erythematosus

• an angiotensin II receptor blocker (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems.

• aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

You must tell your doctor if you think that you are (or might become) pregnant. Ramipril STADA 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 below on “Pregnancy and breast-feeding”).

Childrenand adolescents

Ramipril STADA is not recommended for use in children and adolescents below 18 years of age because safety and efficacy of ramipril in children has not yet been established.

Other medicines and Ramipril STADA

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Ramipril STADA can affect the way some other medicines work. Also some medicines can affect the way Ramipril STADA works.

Please tell your doctor if you are taking any of the following medicines. They can make Ramipril STADA work less well:

• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indometacin and acetylsalicylic acid)

• Medicines used for the treatment of low blood pressure, shock, cardiac failure, asthma or allergies such as ephedrine, noradrenaline or adrenaline. Your doctor will need to check your blood pressure.

Please tell your doctor if you are taking any of the following medicines. They can increase the chance of getting side effects if you take them with Ramipril STADA:

• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indometacin and acetylsalicylic acid)

• Medicines for cancer (chemotherapy)

• Medicines to stop the rejection of organs after a transplant such as ciclosporin

• Diuretics (water tablets) such as furosemide

• Medicines which can increase the amount of potassium in your blood such as spironolactone, triamterene, amiloride, potassium salts and heparin (for thinning blood)

• Steroid medicines for inflammation such as prednisolone

• Allopurinol (used to lower the uric acid in your blood)

• Procainamide (for heart rhythm problems).

• Temsirolimus (for cancer)

• Sirolimus, everolimus (for prevention of graft rejection)

• Vildagliptin (used for treating type 2 diabetes)

• Trimethoprim and co-trimoxazole (for infections caused by bacteria)

Please tell your doctor if you are taking any of the following medicines. They may be affected by Ramipril STADA:

• Medicines for diabetes such as oral glucose lowering medicines and insulin. Ramipril STADA may lower your blood sugar amounts. Check your blood sugar amounts closely while taking Ramipril STADA

• Lithium (for mental health problems). Ramipril STADA may increase the amount of lithium in your blood. Your lithium amount will need to be closely checked by your doctor.

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

Ramipril STADA with food, drink and alcohol

• Drinking alcohol with Ramipril STADA may make you feel dizzy or light-headed. If you are concerned about how much you can drink while you are taking Ramipril STADA, discuss this with your doctor as medicines used to reduce blood pressure and alcohol can have additive effects.

• Ramipril STADA may be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You must tell your doctor if you think that you are (or might become) pregnant.

You should not take Ramipril STADA in the first 12 weeks of pregnancy, and you must not take them at all after the 13th week as their use during pregnancy may possibly be harmful to the baby.

If you become pregnant while on Ramipril STADA, tell your doctor immediately. A switch to a

suitable alternative treatment should be carried out in advance of a planned pregnancy.

Breast-feeding

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

Driving and using machines

You may feel dizzy, while taking Ramipril STADA. This is more likely to happen when you start taking Ramipril STADA or start taking a higher dose. If this happens, do not drive or use any tools or machines.

Ramipril STADA contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Ramipril STADA

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

• Take this medicine by mouth at the same time of the day each day.

• Swallow the tablets whole with liquid.

• Do not crush 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 the amount you take until your blood pressure is controlled.

• The maximum dose is 10 mg once daily.

• If you are already taking diuretics (water tablets), your doctor may stop or reduce the amount of the diuretic you take before beginning treatment with Ramipril STADA.

To reduce the risk of you having a heart attack or stroke

• The usual starting dose is 2.5 mg once daily.

• Your doctor may then decide to increase the amount you take.

• The usual dose is 10 mg once daily.

Treatment to reduce or delay the 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 the amount you are taking.

• 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 the amount you take.

• The maximum dose is 10 mg daily. Two administrations per day are preferable.

Treatment after you have had a heart attack

• The usual starting dose is 1.25 mg once daily to 2.5 mg twice daily.

• Your doctor will adjust the amount you take.

• The usual dose is 10 mg daily. Two administrations per day are preferable.

Older people

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

If you take more Ramipril STADA than you should

Tell a doctor or go to the nearest hospital casualty department straight away. Do not drive to the hospital, get somebody else to take you or call for an ambulance. Take the medicine pack with you. This is so the doctor knows what you have taken.

If you forget to take Ramipril STADA

• If you miss a dose, take your normal dose when it is next due.

• Do not take a double dose to make up for a forgotten tablet.

If you have any further questions on 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 everybody gets them.

Stop taking Ramipril STADA and see a doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:

• Swelling of the face, lips or throat which make it difficult to swallow or breathe, as well as itching and rashes. This could be a sign of a severe allergic reaction to Ramipril STADA

• Severe skin reactions including rash, ulcers in your mouth, worsening of a pre-existing skin disease, reddening, blistering or detachment of skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiform).

Tell your doctor immediately if you experience:

• Faster heart rate, uneven or forceful heartbeat (palpitations), chest pain, tightness in your chest or more serious problems including heart attack and stroke

• Shortness of breath or a cough. These could be signs of lung problems

• Bruising more easily, bleeding for longer than normal, any sign of bleeding (e.g. bleeding from the gums), purple spots blotching on the skin or getting infections more easily than usual, sore throat and fever, feeling tired, faint, dizzy or having pale skin. These can be signs of blood or bone marrow problems

• Severe stomach pain which may reach through to your back. This could be a sign of pancreatitis (inflammation of the pancreas).

• Fever, chills, tiredness, loss of appetite, stomach pain, feeling sick, yellowing of your 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:

Please tell your doctor if any of the following gets serious or lasts longer than a few days.

Common (may affect up to 1 in 10 people)

• Headache or feeling tired

• Feeling dizzy. This is more likely to happen when you start taking Ramipril STADA or start taking a higher dose

• Fainting, hypotension (abnormally low blood pressure), especially when you stand or sit up quickly

• Dry tickly cough, inflammation of your sinuses (sinusitis) or bronchitis, shortness of breath

• Stomach or gut pain, diarrhoea, indigestion, feeling or being sick

• Skin rash with or without raised area

• Chest pain

• Cramps or pain in your muscles

• Blood tests showing more potassium than usual in your blood.

Uncommon (may affect up to 1 in 100 people)

• Balance problems (vertigo)

• Itching and unusual skin sensations such as numbness, tingling, pricking, burning or creeping on your skin (paraesthesia)

• Loss or change in the way things taste

• Sleep problems

• Feeling depressed, anxious, more nervous than usual or restless

• Blocked nose, difficulty breathing or worsening of asthma

• A swelling in your gut called “intestinal angioedema” presenting with symptoms like abdominal pain, vomiting and diarrhoea

• Heartburn, constipation or dry mouth

• Passing more water (urine) than usual over the day

• Sweating more than usual

• Loss or decrease of appetite (anorexia)

• Increased or irregular heartbeats, swollen arms and legs. This may be a sign of your body holding onto more water than usual

• Flushing

• Blurred vision

• Pain in your joints

• Fever

• Sexual inability in men, reduced sexual desire in men or women

• An increased number of certain white blood cells (eosinophilia) found during a blood test

• Blood tests showing changes in the way your liver, pancreas or kidneys are working.

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

• Feeling shaky or confused

• Red and swollen tongue

• Severe flaking or peeling of the skin, itchy, lumpy rash

• Nail problem (e.g. loosening or separation of a nail from its bed)

• Skin rash or bruising

• Blotches on your skin and cold extremities

• Red, itchy, swollen or watery eyes

• Disturbed hearing and ringing in your ears

• Feeling weak

• Blood tests showing a decrease in the number of red blood cells, white blood cells or platelets or in the amount of haemoglobin.

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

Other side effects reported / not known (frequency cannot be estimated from the available data):

Please tell your doctor if any of the following gets serious or lasts longer than a few days.

• Difficulty concentrating

• Swollen mouth

• Blood tests showing too few blood cells in your blood

• Blood tests showing less sodium than usual in your blood

• Fingers and toes changing colour when you are cold and then tingling or feeling painful when you warm up (Raynaud's phenomenon)

• Breast enlargement in men

• Slowed or impaired reactions

• Burning sensation

• Change in the way things smell

• Hair loss.

• Concentrated urine (dark in colour), feeling or being sick, muscle cramps, confusion and fits which may be due to inappropriate ADH (anti-diuretic hormone) secretion. If you have these symptoms contact your doctor as soon as possible.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ramipril STADA

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

Do not use this medicine after the expiry date which is stated on the blister, bottle and carton after EXP. The expiry date refers to the last day of that month. Do not store Ramipril STADA above 25 °C.

Blister packs: Store in the original package.

Plastic bottle: Keep container tightly closed.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ramipril STADA contains

• The active substance is ramipril 2.5 mg, 5 mg or 10 mg.

• The other ingredients are sodium hydrogen carbonate, lactose monohydrate, croscarmellose sodium, pregelatinised starch (maize), and sodium stearyl fumarate.

• In addition the 2.5 mg tablets contain yellow iron oxide (E 172) and the 5 mg tablets contain yellow iron oxide (E172) and red iron oxide (E 172).

What Ramipril STADA looks like and contents of the pack

• 2.5 mg tablet: capsule-shaped, flat, yellow tablet, scored on one side, printed with R2.

• 5 mg tablet: capsule-shaped, flat, pink tablet, scored on one side, printed with R3.

• 10 mg tablet: capsule-shaped, flat, white tablet, scored on one side, printed with R4.

Pack sizes:

Blister packs: 10, 14, 20, 28, 30, 42, 50, 56, 98,100 and 105 tablets.

Plastic bottles: 100 and 500 tablets (hospital pack).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

[To be completed nationally]

Manufacturer: Actavis Ltd., BLB016, Bulebel Industrial Estate Zejtun ZTN 3000, Malta

Sanico N.V., Industriezone IV, Veejijk 59, 2300 Turnhout, Belgium

STADA Arzneimittel AG, Stadastraße 2-18, 61118 Bad Vilbel, Germany

Clonmel Healthcare Ltd., Waterford Road, Clonmel, Co. Tipperary, Ireland

This medicinal product is authorised in the Member States of the EEA under the following names:

Belgium Ramipril EG 2,5 mg, / 5 mg /10 mg tabletten

Ireland Ramitace 2.5 mg /, 5 mg / 10 mg Tablets

Italy Ramipril Eurogenerici 2.5 mg /,5 mg, / 10mg compresse

Luxembourg Ramipril EG 2,5 mg, 5 mg and 10 mg tablet

Poland RAMISTAD2,5,/ 5 /10

Sweden Ramipril STADA 2,5 mg /, 5 mg 10 mg tablett

This leaflet was last revised 2016-08-24.

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.