Package leaflet: Information for the user • If you are taking any of the following medicines used to treat high blood Ramipril 5 mg tablets pressure: - an “angiotensin II receptor blocker” Ramipril 10 mg tablets (ARBs) (also known as sartans - Ramipril for example valsartan, telmisartan, irbesartan), in particular if you have Read all of this leaflet carefully before diabetes-related kidney problems. you start taking this medicine because - aliskiren it contains important information for Your doctor may check your kidney you. function, blood pressure, and the amount - Keep this leaflet. You may need to of electrolytes (e.g. potassium) in your read it again. blood at regular intervals. - If you have any further questions, ask your doctor or pharmacist. See also information under the heading - This medicine has been prescribed for “Do not take Ramipril” you only. Do not pass it on to others. It Children and adolescents may harm them, even if their signs of Ramipril is not recommended for use illness are the same as yours. in children and adolescents below 18 - If you get any side effects, talk to your years of age because safety and efficacy doctor or pharmacist. This includes of Ramipril in children has not yet been any possible side effects not listed in established. this leaflet. See section 4. If any of the above apply to you (or you What is in this leaflet: are not sure), talk to your doctor before 1. What Ramipril is and what it is used for taking Ramipril. 2. What you need to know before you take Ramipril Other medicines and Ramipril 3. How to take Ramipril Please tell your doctor or pharmacist if you 4. Possible side effects are taking, have recently taken or might 5. How to store Ramipril take any other medicines. This is because 6. Contents of the pack and other Ramipril can affect the way some other information medicines work. Also some medicines can affect the way Ramipril works. 1. What Ramipril is and what it is Tell your doctor if you are taking any of the used for following medicines. They can make the Ramipril Tablets contain a medicine effect of Ramipril work less well: called ramipril. This belongs to a group • Medicines used to relieve pain and of medicines called ACE inhibitors inflammation (e.g. Non-Steroidal Anti- (Angiotensin Converting Enzyme Inflammatory Drugs (NSAIDs) such as

Half Fold : 320 mm Inhibitors). ibuprofen or indometacin and aspirin) • Medicines used for the treatment of Ramipril works by: low blood pressure, shock, cardiac • Decreasing your body’s production of failure, asthma or allergies such substances that could raise your blood as ephedrine, noradrenaline or pressure adrenaline. Your doctor will need to • Making your blood vessels relax and check your blood pressure. widen • Making it easier for your heart to pump Tell your doctor if you are taking any of the blood around your body. following medicines. They can increase the chance of getting side effects if you Ramipril can be used: take them with Ramipril: • To treat high blood pressure • Sacubitril/valsartan – used for treating (hypertension) • To reduce the risk of you having a a type of long term (chronic) heart heart attack or stroke failure in adults (see section 2 ‘Do not • To reduce the risk or delay the take Ramipril’) worsening of kidney problems • Medicines used to relieve pain and (whether or not you have diabetes) inflammation (e.g. Non-Steroidal Anti- • To treat your heart when it cannot Inflammatory Drugs (NSAIDs) such as pump enough blood to the rest of your ibuprofen or indometacin and aspirin) body (heart failure) • Medicines for cancer (chemotherapy) • As treatment following heart attack • Medicines to stop the rejection of (myocardial infarction) complicated organs after a transplant such as with heart failure. ciclosporin • Diuretics (water tablets) such as 2. What you need to know before you furosemide take Ramipril • Potassium supplements (including salt substitutes), potassium-sparing Do not take Ramipril diuretics and other medicines that can • If you are allergic to ramipril, any other increase the amount of potassium ACE inhibitor medicine or any of the in your blood (e.g. trimethoprim ingredients of this medicine (listed in and co-trimoxazole for infections section 6). caused by bacteria; ciclosporin, an Signs of an allergic reaction may immunosuppressant medicine used to include a rash, swallowing or breathing prevent organ transplant rejection; and problems, swelling of your lips, face, heparin, a medicine used to thin blood throat or tongue. to prevent clots) • If you have ever had a serious allergic • Steroid medicines for inflammation reaction called “angioedema”. The such as prednisolone signs include itching, hives (urticaria), • Allopurinol (used to lower the uric acid red marks on the hands, feet and in your blood) throat, swelling of the throat and • Procainamide (for heart rhythm tongue, swelling around the eyes and problems). lips, difficulty breathing and swallowing • Temsirolimus (for cancer) • If you have taken or are currently • Medicines which are most often used taking sacubitril/ valsartan, a medicine to avoid rejection of transplanted used to treat a type of long-term organs (sirolimus, everolimus and (chronic) heart failure in adults, as the other medicines belonging to the risk of angioedema (rapid swelling class of mTOR inhibitors). See section under the skin in an area such as the “Warnings and precautions”. throat) is increased. • Vildagliptin (used for treating type 2 • If you are having dialysis or any diabetes) other type of blood filtration. • Racecadotril (used against diarrhoea) Depending on the machine that • Your doctor may need to change your is used, Ramipril may not be dose and/or to take other precautions suitable for you if you are taking an angiotensin II • If you have kidney problems receptor blocker (ARB) or aliskiren where the blood supply to your (see also information under the kidney is reduced (renal artery headings “Do not take Ramipril” and stenosis) “Warnings and precautions”). • During the last 6 months of Tell your doctor if you are taking any of the pregnancy (see section below following medicines. They may be affected on “Pregnancy and breast- by Ramipril: feeding”) • Medicines for diabetes such as oral • If your blood pressure is abnormally glucose lowering medicines and low or unstable. Your doctor will need insulin. Ramipril may lower your blood to make this assessment. sugar amounts. Check your blood • If you have diabetes or impaired sugar amounts closely while taking kidney function and you are treated Ramipril with a blood pressure lowering • Lithium (for mental health problems). medicine containing aliskiren Ramipril may increase the amount • If you are taking any of the following of lithium in your blood. Your lithium medicines, the risk of angioedema may amount will need to be closely checked be increased: by your doctor. - Racecadotril, a medicine used If any of the above apply to you (or you to treat diarrhoea; are not sure), talk to your doctor before - Medicines used to prevent organ taking Ramipril. transplant rejection and for cancer (e.g., temsirolimus, sirolimus, Ramipril with food, drink and alcohol everolimus). • Drinking alcohol with Ramipril may - Vildagliptin, a medicine used to make you feel dizzy or light-headed. treat diabetes. If you are concerned about how much Do not take Ramipril if any of the above you can drink while you are taking apply to you. If you are not sure, talk to Ramipril, discuss this with your doctor your doctor before taking Ramipril. as medicines used to reduce blood pressure and alcohol can have additive Warnings and precautions Talk to your doctor or pharmacist before effects. taking Ramipril: • Ramipril may be taken with or without • If you have heart, liver or kidney food. problems Pregnancy, breast-feeding and fertility • If you have lost a lot of body salts or Pregnancy fluids (through being sick (vomiting), You must tell your doctor if you think you having diarrhea, sweating more than are (or might become) pregnant. You usual, being on a low salt diet, taking should not take Ramipril in the first 12 diuretics (water tablets) for a long time weeks of pregnancy, and you must not or having had dialysis) take them at all after the 13th week as • If you are going to have treatment to their use during pregnancy may possibly reduce your allergy to bee or wasp be harmful to the baby. If you become stings (desensitization) pregnant while on Ramipril, tell your • If you are going to receive an doctor immediately. A switch to a suitable anaesthetic. This may be given for an alternative treatment should be carried out operation or any dental work. You may in advance of a planned pregnancy. need to stop your Ramipril treatment one day beforehand; ask your doctor Breast-feeding for advice You should not take Ramipril if you • If you have high amounts of potassium are breast-feeding. Ask your doctor or in your blood (shown in blood test pharmacist for advice before taking any results) medicine. • If you are taking medicines or have Driving and using machines conditions which may decrease You may feel dizzy, while taking Ramipril. sodium levels in your blood. Your This is more likely to happen when you doctor may carry out regular blood start taking Ramipril or start taking a tests, particularly for checking the higher dose. If this happens, do not drive levels of sodium in your blood or use any tools or machines. especially if you are elderly. • If you are taking any of the following Ramipril Tablets contains lactose medicines, the risk of angioedema monohydrate. If you have been told by (rapid swelling under the skin in area your doctor that you have an intolerance such as the throat) is increased: to some sugars, contact your doctor - Temsirolimus, sirolimus, everolimus before taking this medicinal product. and other medicines belonging This medicine contains less than 1 mmol to the class of mTOR inhibitors sodium (23 mg) per each film-coated (used to avoid rejection of tablet, that is to say essentially ‘sodium- transplanted organs), vildagliptin, free’. neprilysin (NEP) inhibitors (such as racecadontril) or sacubitril/ 3. How to take Ramipril valsartan. For sacubitril/valsartan, see section 2 “Do not take Always take this medicine exactly as Ramipril”. your doctor has told you. Check with your • If you have collagen vascular disease doctor or pharmacist if you are not sure. such as scleroderma or systemic lupus Ramipril 5 mg tablets: erythematosus This strength is not suitable for dosages • You must tell your doctor if you below 2.5mg think that you are (or might Ramipril 10 mg tablets: become) pregnant. Ramipril is not This strength is not suitable for recommended in the first 3 months dosages below 5 mg of pregnancy and may cause serious For doses less than 2.5 mg per harm to your baby after 3 months day Ramipril is not suitable. Other of pregnancy (see section below medicinal products of ramipril in “Pregnancy and breast-feeding”).

adequate strength are available. P1521643

Black A/s : 135 x 640 mm

Product Name Component Item Code Date & Time Ramipril tablets Leaflet P1521643 10.06.2019 & 10.10 AM

Customer / Country Version No. Reason Of Issue Reviewed / Approved Packaging Development by UK_MIlpham_Unit-15 00 Revision

Team Leader Ramesh P Dimensions No. of Colours : 01

Initiator Kiranmai 135 x 640 mm

Artist: Pharmacode 21643

Additional Information : Supersede Item Code: P1520516 Sign / Date Your doctor will advise you accordingly. • Increased or irregular heartbeat • Swollen arms and legs. This may be How much to take a sign of your body holding onto more Treatment of high blood pressure water than usual • The usual starting dose is 1.25 mg or • Flushing 2.5 mg once daily. • Blurred vision • Your doctor will adjust the amount • Pain in your joints you take until your blood pressure is • Fever controlled. • Sexual inability in men, reduced sexual • The maximum dose is 10 mg once desire in men or women daily. • An increased number of certain white • If you are already taking diuretics blood cells (eosinophilia) found during (water tablets), your doctor may stop a blood test or reduce the amount of the diuretic • Blood tests showing changes in the you take before beginning treatment way your liver, pancreas or kidneys with Ramipril. are working To reduce the risk of you having a heart Rare (may affect up to 1 in 1,000 people) attack or stroke • Feeling shaky or confused • The usual starting dose is 2.5 mg once • Red and swollen tongue daily. • Severe flaking or peeling of the skin, • Your doctor may then decide to itchy, lumpy rash increase the amount you take. • Nail problems (e.g. loosening or • The usual dose is 10 mg once daily. separation of a nail from its bed) Treatment to reduce or delay the • Skin rash or bruising worsening of kidney problems • Blotches on your skin and cold • You may be started on a dose of extremities 1.25 mg or 2.5 mg once daily. • Red, itchy, swollen or watery eyes • Your doctor will adjust the amount you • Disturbed hearing and ringing in your are taking. ears • The usual dose is 5 mg or 10 mg once • Feeling weak daily. • Blood tests showing a decrease in the Treatment of heart failure number of red blood cells, white blood • The usual starting dose is 1.25 mg cells or platelets or in the amount of once daily. haemoglobin. • Your doctor will adjust the amount you Very rare (may affect up to 1 in 10,000 take. people) • The maximum dose is 10 mg daily. • Being more sensitive to the sun than Two administrations per day are usual

Half Fold : 320 mm preferable. Other side effects reported: Treatment after you have had a heart Tell your doctor if any of the following gets attack serious or lasts longer than a few days. • The usual starting dose is 1.25 mg • Difficulty concentrating once daily to 2.5 mg twice daily. • Swollen mouth • Your doctor will adjust the amount you • Blood tests showing too few blood take. • The usual dose is 10 mg daily. Two cells in your blood administrations per day are preferable. • Blood tests showing less sodium than usual in your blood Elderly • Concentrated urine (dark in colour), Your doctor will reduce the initial dose and feel or are sick, have muscle cramps, adjust your treatment more slowly. confusion and fits which may be due Taking this medicine to inappropriate ADH (anti-diuretic • Take this medicine by mouth at the hormone) secretion. If you have these same time of the day each day. symptoms contact your doctor as soon • Swallow the tablets whole with liquid. as possible. • Do not crush or chew the tablets. • Fingers and toes changing colour when you are cold and then tingling If you take more Ramipril than you or feeling painful when you warm up should Tell a doctor or go to the nearest hospital (Raynaud’s phenomenon) casualty department straight away. Do not • Breast enlargement in men drive to the hospital, get somebody else • Slowed or impaired reactions to take you or call for an ambulance. Take • Burning sensation the medicine pack with you. This is so the • Change in the way things smell doctor knows what you have taken. • Hair loss If you forget to take Ramipril Reporting of side effects • If you miss a dose, take your normal If you get any side effects, talk to your dose when it is next due. doctor or pharmacist or nurse. This • Do not take a double dose to make up includes any possible side effects not for a forgotten tablet/capsule. listed in this leaflet. You can also report side effects directly via the national If you have any further questions on the reporting system listed in Yellow Card use of this medicine, ask your doctor or Scheme Website: www.mhra.gov.uk/ pharmacist. yellowcard. or search for MHRA Yellow 4. Possible side effects Card in the Google Play or Apple App Store. By reporting side effects you can Like all medicines, this medicine help provide more information on the can cause side effects, although not safety of this medicine. everybody gets them. 5. How to store Ramipril Stop taking Ramipril and see a doctor straight away, if you notice any of the Keep this medicine out of the sight and following serious side effects – you reach of children. may need urgent medical treatment: 0 • Swelling of the face, lips or throat Store below 25 C. which make it difficult to swallow or Store in the original package in order to breathe, as well as itching and rashes. protect from moisture. This could be a sign of a severe Keep the HDPE container tightly closed in allergic reaction to Ramipril order to protect from moisture. • Severe skin reactions including Do not use this medicine after the expiry rash, ulcers in your mouth, date which is stated on the carton, bottle, worsening of a pre-existing skin label and blister foil after EXP. The expiry disease, reddening, blistering date refers to the last day of that month. or detachment of skin (such as Stevens-Johnson syndrome, toxic Do not throw away any medicines via epidermal necrolysis or erythema wastewater or household waste. Ask your multiform). pharmacist how to throw away medicines you no longer use. These measures will Tell your doctor immediately if help protect the environment. you experience: • Faster heart rate, uneven or 6. Contents of the pack and other forceful heartbeat (palpitations), information chest pain, tightness in your chest or more serious problems What Ramipril Tablets contain including heart attack and - The active substance is ramipril. Each stroke tablet contains 5 mg or 10 mg of • Shortness of breath or a cough. These ramipril. could be signs of lung problems - The other ingredients are starch • Bruising more easily, bleeding for pregelatinised (maize), lactose longer than normal, any sign of monohydrate, sodium hydrogen bleeding (e.g. bleeding from the carbonate (E500), croscarmellose gums), purple spots blotching sodium (E468), iron oxide red [for 5mg on the skin or getting infections tablets only] (E172) and sodium stearyl more easily than usual, sore fumarate. throat and fever, feeling tired, What Ramipril Tablets look like and faint, dizzy or having pale skin. contents of the pack These can be signs of blood or Ramipril 5 mg tablets: bone marrow problems Light pink coloured mottled, flat faced • Severe stomach pain which may reach bevel edged round [diameter 6.0 mm] through to your back. This could be a uncoated tablet debossed with “H” and sign of pancreatitis (inflammation of “19” separated by scoreline on one side the pancreas) and plain on other side. The tablet can be • Fever, chills, tiredness, loss of divided into two equal doses. appetite, stomach pain, feeling sick, yellowing of your skin or eyes Ramipril 10 mg tablets: (jaundice). These can be signs of White to Off-white colored, flat faced liver problems such as hepatitis bevel edged round [diameter 8.0 mm] (inflammation of the liver) or liver uncoated tablet debossed with “H” and damage. “20” separated by scoreline on one side and plain on the other side. The tablet can Other side effects include: Please tell your doctor if any of the be divided into two equal doses. following gets serious or lasts longer than Ramipril tablets are available in: a few days. Blister pack (Clear - PVC/ Aluminium). Common (may affect up to 1 in 10 - White opaque HDPE container with PP people) screw cap • Headache or feeling tired Pack sizes: • Feeling dizzy. This is more likely to Ramipril 5 mg tablets: happen when you start taking Ramipril Blister pack: 7, 10, 14, 20, 28, 30, 42, 50, or start taking a higher dose 56, 60, 90, 98, 100 and 500 tablets • Fainting, hypotension (abnormally low HDPE container pack: 30 and 1000 blood pressure), especially when you (clinical pack) tablets stand or sit up quickly Ramipril 10 mg tablets: • Dry tickly cough, inflammation of your sinuses (sinusitis) or bronchitis, Blister pack: 20, 28, 30, 50, 56, 60, 90, 98, shortness of breath 100 and 500 tablets • Stomach or gut pain, diarrhea, HDPE container pack: 30 and 1000 indigestion, feeling or being sick (clinical pack) tablets • Skin rash with or without raised area Not all pack sizes may be marketed. • Chest pain Marketing Authorisation Holder • Cramps or pain in your muscles Milpharm Limited • Blood tests showing more potassium Ares, Odyssey Business Park, West End than usual in your blood. Road, Uncommon (may affect up to 1 in 100 South Ruislip HA4 6QD. people) United Kingdom • Balance problems (vertigo) Manufacturer • Itching and unusual skin sensations Milpharm Limited such as numbness, tingling, pricking, Ares, Odyssey Business Park, West End burning or creeping on your skin Road, (paraesthesia) South Ruislip HA4 6QD. • Loss or change in the way things taste United Kingdom • Sleep problems • Feeling depressed, anxious, more or nervous than usual or restless APL Swift Services (Malta) Limited • Blocked nose, difficulty breathing or HF26, Hal Far Industrial Estate worsening of asthma Hal Far, Birzebbugia, BBG 3000 • A swelling in your gut called Malta “intestinal angioedema” presenting with symptoms like abdominal pain, or vomiting and diarrhoea Galenicum Health, S.L. • Heartburn, constipation or dry mouth Avenida Diagonal 538, 4º 1ª • Passing more water (urine) than usual 08006, Barcelona, Spain over the day • Sweating more than usual This leaflet was last revised in • Loss or decrease of appetite 04/2019. (anorexia) P1521643