OLMETEC PLUS 40MG/12.5MG FILM-COATED TABLETS

Package Leaflet: Information for the User

Olmetec Plus 40 mg/12.5 mg
Film-Coated Tablets
Olmesartan medoxomil/Hydrochlorothiazide

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 further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet: 1. What Olmetec Plus is and what it is used for 2. Before you take Olmetec Plus 3. How to take Olmetec Plus 4. Possible side effects 5. How to store Olmetec Plus 6. Further information

1. What Olmetec Plus is and what it is used for Olmetec Plus contains two active substances, olmesartan medoxomil and hydrochlorothiazide, that are used to treat high blood pressure (hypertension): Olmesartan medoxomil is one of a group of medicines called angiotensin II-receptor antagonists. It lowers blood pressure by relaxing the blood vessels. Hydrochlorothiazide is one of a group of medicines called thiazide diuretics (water tablets). It lowers blood pressure by helping the body to get rid of extra fluid by making your kidneys produce more urine. You will only be given Olmetec Plus if Olmetec (olmesartan medoxomil) alone has not adequately controlled your blood pressure. When given together, the two active substances in Olmetec Plus help to lower blood pressure more than if either of them were given alone. You may already be taking medicines to treat your high blood pressure, but your doctor may want you to take Olmetec Plus to lower it more. High blood pressure can be controlled with medicines such as Olmetec Plus tablets. Your doctor has probably also recommended that you make some changes in your lifestyle to help lower your blood pressure (for example losing weight, giving up smoking, reducing the amount of alcohol you drink and reducing the amount of salt in your diet). Your doctor may also have urged you to take regular exercise, such as walking or swimming. It is important to follow this advice from your doctor.

potassium supplements (as well as salt substitutes containing potassium) water tablets (diuretics) heparin (for thinning the blood) laxatives steroids adrenocorticotrophic hormone (ACTH) carbenoxolone (a medicine used to treat mouth and stomach ulcers) penicillin G sodium (also called benzylpenicillin sodium, an antibiotic) certain pain killers such as aspirin or salicylates Lithium (a medicine used to treat mood swings and some types of depression) used at the same time as Olmetec Plus may increase the toxicity of lithium. If you have to take lithium, your doctor will measure your lithium blood levels Non-steroidal anti-inflammatory (NSAIDs) medicines (medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis) used at the same time as Olmetec Plus may increase the risk of kidney failure and the effect of Olmetec Plus can be decreased by NSAIDs Other blood pressure lowering medicines (anti-hypertensives), as the effect of Olmetec Plus can be increased Sleeping tablets, sedatives and anti-depressant medicines, as using these medicines together with Olmetec Plus may cause a sudden drop in blood pressure when standing up Certain medicines such as baclofen and tubocurarine, used to relax muscles Amifostine and some other drugs used to treat cancers, such as cyclophosphamide or methotrexate Colestyramine and colestipol, medicines for lowering blood fat levels Anticholinergic agents, such as atropine and biperiden Drugs such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol or haloperidol, used to treat certain psychiatric disorders Certain medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol or digitalis, used to treat heart problems Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide or erythromycin injections, which may change the heart rhythm Oral anti-diabetic medicines, such as metformin or insulin, used to lower blood sugar Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood sugar, respectively, as Olmetec Plus can enhance their blood-sugar-increasing effect Methyldopa, a medicine used to treat high blood pressure Medicines such as noradrenaline, used to increase blood pressure and slow heart rate Diphemanil, used to treat a slow heartbeat or reduce sweating Medicines such as probenecid, sulfinpyrazone and allopurinol, used to treat gout Calcium supplements Amantadine, an anti-viral drug Ciclosporin, a medicine used to stop rejection of organ transplants Certain antibiotics called tetracyclines or sparfloxacin Amphotericin, a medicine used to treat fungal infections Certain antacids, used to treat too much stomach acid, such as aluminium magnesium hydroxide, as the effect of Olmetec Plus can be slightly decreased. Cisapride, used to increase food movement in the stomach and gut Halofantrine, used for malaria Taking Olmetec Plus with food and drink Olmetec Plus can be taken with or without food. Take care when drinking alcohol while you are taking Olmetec Plus, as some people feel faint or dizzy. If this happens to you, do not drink any alcohol, including wine, beer or alcopops. Children and adolescents (under 18) Olmetec Plus is not recommended for children and adolescents under the age of 18. Black patients As with other similar drugs the blood pressure lowering effect of Olmetec Plus is somewhat less in black patients. Pregnancy and breastfeeding Pregnancy You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Olmetec Plus before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Olmetec Plus. Olmetec Plus is not recommended during pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if it is used after the third month of pregnancy. Breastfeeding Tell your doctor if you are breastfeeding or about to start breastfeeding. Olmetec Plus is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines You may feel sleepy or dizzy while being treated for your high blood pressure. If this happens, do not drive or use machines until the symptoms wear off. Ask your doctor for advice.
GB 109572

2. Before you take Olmetec Plus Do not take Olmetec Plus if you: are allergic (hypersensitive) to olmesartan medoxomil or to hydrochlorothiazide, or to any of the other ingredients in the tablets (Section 6 contains a complete list) or to substances similar to hydrochlorothiazide (sulfonamides) are more than 3 months pregnant (It is also better to avoid Olmetec Plus in early pregnancy see pregnancy section) have kidney problems suffer from low potassium, low sodium, high calcium or high uric acid levels in the blood (with symptoms of gout or kidney stones) that do not get better when treated suffer from moderate or severe liver problems or yellowing of the skin and eyes (jaundice) or problems with drainage of the bile from the gallbladder (biliary obstruction, e.g. gallstones) If you think any of these apply to you, or you are unsure, do not take the tablets. Talk to your doctor first and follow the advice given. Take special care with Olmetec Plus Before you take the tablets, tell your doctor if you have any of the following health problems: Kidney transplant Liver diseases Heart failure or problems with your heart valves or heart muscles Vomiting (being sick) or diarrhoea which is severe or it goes on for several days Treatment with high doses of water tablets (diuretics) or if you are on a low salt diet Problems with your adrenal glands (e.g. primary aldosteronism) Diabetes Lupus erythematosus (an autoimmune disease) Allergies or asthma. Your doctor may want to see you more often and do some tests if you have any of these conditions. Olmetec Plus may cause a rise in blood fat levels and uric acid levels (the cause of gout painful swelling of the joints). Your doctor will probably want to do a blood test from time to time to check these. It may change the levels of certain chemicals in your blood called electrolytes. Your doctor will probably want to do a blood test from time to time to check these. Signs of electrolyte changes are: thirst, dryness of the mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, sluggish, tired, sleepy or restless, nausea, vomiting, less need to pass urine, a rapid heart rate. Tell your doctor if you notice these symptoms. As with any medicine which reduces blood pressure, an excessive drop in blood pressure in patients with blood flow disturbances of the heart or brain could lead to a heart attack or stroke. Your doctor will therefore check your blood pressure carefully. If you are due to have tests for parathyroid function, you should stop taking Olmetec Plus before these tests are carried out. If you are a sports person, this medicine could change the results of an anti-dope test to make it positive. You must tell your doctor if you think that you are (or might become) pregnant. Olmetec Plus is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section). Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription. In particular, tell your doctor or pharmacist about any of the following: Medicines which may raise the levels of potassium in your blood if used at the same time as Olmetec Plus. These include:

Important information about some of the ingredients of Olmetec Plus Lactose: This medicine contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Hydrochlorothiazide: Very common side effects: Changes in blood results including: Increase in blood fat and uric acid levels. Common side effects: Feeling confused, abdominal pain, stomach upset, bloated feeling, diarrhoea, nausea, vomiting, constipation, excretion of glucose into the urine. Some changes in blood results have also been seen and include: Increase in blood creatinine, urea, calcium and sugar levels, decrease in blood chloride, potassium, magnesium and sodium levels. Increase of serum amylase (hyperamylasaemia). Uncommon side effects: Decreased or loss of appetite, severe difficulty breathing, anaphylactic skin reactions (hypersensitivity reactions), worsening of pre-existing myopia erythema, skin reactions to light, itching, purplish spots or patches on the skin due to small hemorrhages (purpura), skin lumps (wheals). Rare side effects: Swollen and sore salivary glands, decreased number of white blood cells, decreased number of blood platelets, anaemia, bone marrow damage, restlessness, feeling down or depressed, problems sleeping, feeling uninterested (apathy), tingling and numbness, fits (convulsions), objects you look at appearing yellow, blurred vision, dry eyes, irregular heart beat, inflammation of the blood vessels, blood clots (thrombosis or embolism), inflammation of the lung, fluid accumulation in the lungs, inflammation of the pancreas, jaundice, infection in the gall bladder, symptoms of lupus erythematosus (such as rash, joint pains and cold hands and fingers), allergic skin reactions, peeling and blistering of the skin, non-infectious inflammation of the kidney (interstitial nephritis), fever, muscle weakness (sometimes causing impaired movement). Very rare side effects: Electrolyte disturbance leading to an abnormally depleted level of chloride in the blood (hypochloraemic alkalosis), blockage in the gut (paralytic ileus). If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

3. How to take Olmetec Plus Always take Olmetec Plus exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is one Olmetec Plus 40 mg/12.5 mg tablet a day. Swallow the tablet with water. If possible, you should take your dose at the same time each day, for example at breakfast time. It is important to continue to take Olmetec Plus until your doctor tells you to stop. If you take more Olmetec Plus than you should If you take more tablets than you should, or if a child accidentally swallows one or more, go to your doctor or nearest accident and emergency (A&E) department immediately and take your medicine pack with you. If you forget to take Olmetec Plus If you forget to take a dose, take your normal dose on the following day as usual. Do not take any extra tablets to make up for the missed dose. If you stop taking Olmetec Plus It is important to continue to take Olmetec Plus unless your doctor tells you to stop. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects Like all medicines, Olmetec Plus can cause side effects, although not everybody gets them. However, the following two side effects can be serious: Allergic reactions that may affect the whole body, with swelling of the face, mouth and/or voice box (larynx) together with itching and rash may occur very rarely. If this happens, stop taking Olmetec Plus and contact your doctor immediately. Olmetec Plus can cause the blood pressure to fall too low in susceptible individuals or as the result of an allergic reaction. Light-headedness or fainting may occur uncommonly. If this happens, stop taking Olmetec Plus, contact your doctor immediately and lie down flat. Olmetec Plus is a combination of two active substances and the following information firstly gives the other side effects reported so far with the combination Olmetec Plus (besides those already mentioned above) and, secondly, those which are known about for the separate active substances. To give you an idea of how many patients might get side effects, they have been listed as common, uncommon, rare and very rare. These mean the following: Very common Common Uncommon Rare Very rare affects more than 1 user in 10 affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000

5. How to store Olmetec Plus Keep out of the reach and sight of children. This medicinal product does not require any special storage conditions. Do not use Olmetec Plus after the expiry date which is stated on the carton and on the blister strip as EXP. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information What Olmetec Plus contains The active substances are: Olmetec Plus 40 mg/12.5 mg: Each film-coated tablet contains 40 mg olmesartan medoxomil and 12.5 mg hydrochlorothiazide. The other ingredients are: Microcrystalline cellulose, lactose monohydrate*, low substituted hyprolose, hyprolose, magnesium stearate, titanium dioxide (E 171), talc, hypromellose, iron (III) oxides (E 172). * See Important information about some of the ingredients of Olmetec Plus section above What Olmetec Plus looks like and contents of the pack: Olmetec Plus 40 mg/12.5 mg film-coated tablets are reddish-yellow, oval with "C23" on one side. They are available in packs of 14, 28, 30, 56, 84, 90, 98, 10 x 28 and 10 x 30 film-coated tablets and in packs with perforated unit dose blisters of 10, 50 and 500 film-coated tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder DAIICHI SANKYO UK LTD Chiltern Place, Chalfont Park, Gerrards Cross Buckinghamshire SL9 0BG UK Manufacturer DAIICHI SANKYO EUROPE GmbH Luitpoldstrasse 1 85276 Pfaffenhofen, Germany Date of approval of this leaflet: April 2012 UK: Olmetec 40 mg/12.5 mg Film-Coated Tablets: The following pack sizes are currently marketed: 28 film-coated tablets.

These are the other side effects known about so far with Olmetec Plus: If these side effects occur, they are often mild and you do not need to stop your treatment. Common side effects: Dizziness, weakness, headache, tiredness, chest pain, swelling of ankles, feet, legs, hands or arms. Uncommon side effects: Fluttering of the heart beat (palpitations), rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhoea, muscle cramps and muscular pain, pain in joints, arms and legs, back pain, erection difficulties in men, blood in urine. Some changes in blood test results have also been seen uncommonly and include: Rise in blood fat levels, rise in blood urea or uric acid, rise in creatinine, rise or decrease in blood potassium levels, rise in blood calcium levels, rise in blood sugar, increase in levels of liver function. Your doctor will know about these from a blood test and will tell you if you need to do anything. Rare side effects: Feeling unwell, disturbances in consciousness, skin lumps (wheals), acute kidney failure. Some changes in blood test results have also been seen in rare cases and include: Rise in blood urea nitrogen, decrease in haemoglobin and haematocrit values. Your doctor will know about these from a blood test and will tell you if you need to do anything. Further side effects reported with use of olmesartan medoxomil or hydrochlorothiazide alone but not with Olmetec Plus or in a higher frequency: Olmesartan medoxomil: Common side effects: Bronchitis, cough, runny or stuffy nose, sore throat, abdominal pain, indigestion, diarrhoea, nausea, gastroenteritis, pain in the joints or bones, back pain, blood in urine, urinary tract infection, flu-like symptoms, pain. Some changes in blood test results have also been seen commonly and include: Rise in blood fat levels, rise in blood urea or uric acid, increase in levels of liver and muscle function. Uncommon side effects: Quick allergic reactions that may affect the whole body and may cause breathing problems as well as a rapid fall of blood pressure that may even lead to fainting (anaphylactic reactions), swelling of the face, angina (pain or uncomfortable feeling in the chest; known as angina pectoris), feeling unwell, allergic skin rash, itching, exanthema (skin eruption), skin lumps (wheals). Some changes in blood test results have also been seen uncommonly and include: Reduced numbers of a type of blood cell, known as platelets (thrombocytopenia). Rare side effects: Impaired kidney function, lack of energy. Some changes in blood test results have also been seen rarely and include: Increase in blood potassium.

Problems reading this leaflet? To listen to or request a copy of this leaflet in Braille, large print or audio, please call, free of charge 0800 198 5000 (UK only) Please be ready to give the following information: Product name: Olmetec Plus 40 mg/12.5 mg Film-Coated Tablets Reference number: PL 08265/0029 This is a service provided by the Royal National Institute of Blind People.