Onduarp
telmisartan, amlodipine
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 of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What Onduarp is and what it is used for
What you need to know before you take Onduarp
How to take Onduarp
Possible side effects
How to store Onduarp
Contents of the pack and other information
Onduarp tablets contain two active substances called telmisartan and amlodipine. Both of these substances help to control your high blood pressure:
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Telmisartan belongs to a group of substances called “angiotensin-II receptor antagonists”. Angiotensin II is a substance produced in the body which causes blood vessels to narrow, thus increasing blood pressure. Telmisartan works by blocking the effect of angiotensin II.
Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine stops calcium from moving into the blood vessel wall which stops the blood vessels from tightening.
This means that both of these active substances work together to help stop your blood vessels tightening. As a result, the blood vessels relax and blood pressure is lowered.
in adult patients whose blood pressure is not controlled enough with amlodipine.
in adult patients who already receive telmisartan and amlodipine from separate tablets and who wish to take instead the same doses in one tablet for convenience.
High blood pressure, if not treated, can damage blood vessels in several organs, which puts patients at risk of serious events such as heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is within the normal range.
if you are allergic to telmisartan or amlodipine or any of the other ingredients of this medicine (listed in section 6).
if you are allergic to other medicines of the dihydropyridine type (one type of calcium channel blocker).
if you are more than 3 months pregnant. (It is also better to avoid Onduarp in early pregnancy – see Warnings and precautions and Pregnancy section.)
if you have severe liver problems or biliary obstruction (problems with drainage of the bile from the liver and gall bladder).
if you suffer from severe low blood pressure (including shock).
if you suffer from low heart output because of a serious heart problem.
if you have diabetes mellitus or impaired kidney function and you are treated with Rasilez. If any of the above applies to you, tell your doctor or pharmacist before taking Onduarp. Warnings and precautions
Talk to your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses:
Kidney disease or kidney transplant.
Narrowing of the blood vessels to one or both kidneys (renal artery stenosis).
Liver disease.
Heart trouble.
Raised aldosterone levels (which lead to water and salt retention in the body along with imbalance of various blood minerals).
Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (‘water tablets’), low-salt diet, diarrhoea, or vomiting.
Elevated potassium levels in your blood.
Diabetes.
Narrowing of the aorta (aortic stenosis).
Heart-associated chest pain also at rest or with minimal effort (unstable angina pectoris).
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A heart attack within the last four weeks.
Talk to your doctor before taking Onduarp:
if you are taking Rasilez, a medicine used to treat high blood pressure.
if you are taking digoxin.
In case of surgery or anaesthesia, you should tell your doctor that you are taking Onduarp.
The use of Onduarp in children and adolescents up to the age of 18 years is not recommended.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may need to change the dose of these other medicines or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below taken at the same time with Onduarp:
Lithium-containing medicines to treat some types of depression.
Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain ‘water tablets’).
ACE inhibitors, angiotensin II receptor antagonists, renin inhibitors.
NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicylic acid or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
Rifampicin, St. John’s wort.
Medicines used for HIV/AIDS (e.g. ritonavir) or for treatment of fungal infections (e.g. ketoconazole).
Erythromycin (antibiotic).
Diltiazem (cardiac medicine).
Simvastatin to treat elevated levels of cholesterol.
Rasilez, a medicine used to treat high blood pressure.
Digoxin.
As with other blood pressure lowering medicines, the effect of Onduarp may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicylic acid or ibuprofen) or corticosteroids.
Onduarp may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine, neuroleptics or antidepressants). Furthermore low blood pressure may be aggravated by alcohol. You may notice this as dizziness when standing up.
See section 3.
Grapefruit juice and grapefruit should not be consumed when you take Onduarp. This is because grapefruit and grapefruit juice may lead to increased blood levels of the active ingredient amlodipine in some patients and may increase the blood pressure lowering effect of Onduarp.
Pregnancy
Medicinal product no longer authorised
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Onduarp before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Onduarp. Onduarp is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Onduarp is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Ask your doctor or pharmacist for advice before taking any medicine.
Some people may experience side effects such as fainting, sleepiness, dizziness or a feeling of spinning (vertigo) when they are treated for high blood pressure. If you experience these side effects, do not drive or use machines.
If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicine.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet a day. Try to take the tablet at the same time each day. Remove your Onduarp tablet from the blister only directly prior to intake.
You can take Onduarp with or without food. The tablets should be swallowed with some water or other non-alcoholic drink.
If your liver is not working properly, the usual dose should not exceed one 40 mg/5 mg tablet or one 40 mg/10 mg tablet per day.
If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately. You might experience low blood pressure and rapid heart beat. Slow heart beat, dizziness, reduced kidney function including kidney failure, marked and prolonged low blood pressure including shock and death have also been reported.
If you forget to take a dose, take it as soon as you remember and then carry on as before. If you do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make up for forgotten individual doses.
It is important that you take Onduarp every day until your doctor tells you otherwise. If you have the impression that the effect of Onduarp is too strong or too weak, talk to your doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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You should see your doctor immediately if you experience any of the following symptoms:
Sepsis (often called "blood poisoning", is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately. If these effects are not treated they could be fatal. Increased incidence of sepsis has been observed with telmisartan only, however can not be ruled out for Onduarp.
Common side effects (may affect up to 1 in 10 people): Dizziness, ankle swelling (oedema).
Uncommon side effects (may affect up to 1 to 100 people):
Sleepiness, migraine, headache, tingling or numbness of the hands or feet, feeling of spinning (vertigo), slow heart rate, palpitations (awareness of your heart beat), low blood pressure (hypotension), dizziness on standing up (orthostatic hypotension), flushing, cough, stomach ache (abdominal pain), diarrhoea, feeling sick (nausea), itching, joint pain, muscle cramps, muscle pain, inability to obtain an erection, weakness, chest pain, tiredness, swelling (oedema), increased levels of hepatic enzymes.
Rare side effects (may affect up to 1 in 1,000 people):
Urinary bladder infection, feeling sad (depression), feeling anxious, sleeplessness, fainting, nerve damage in the hands or feet, reduced sense of touch, taste abnormalities, trembling, vomiting, enlarged gums, discomfort in the abdomen, dry mouth, eczema (a skin disorder), redness of skin, rash, back pain, leg pain, urge to urinate during the night, feeling unwell (malaise), increased levels of uric acid in the blood.
The following side effects have been observed with the components telmisartan or amlodipine and may occur also with Onduarp:
Telmisartan
In patients taking telmisartan alone the following additional side effects have been reported:
Uncommon side effects (may affect up to 1 in 100 people):
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels in the blood, shortness of breath, bloating, increased sweating, kidney damage including sudden inability of the kidneys to work, increased levels of creatinine.
Rare side effects (may affect up to 1 in 1,000 people):
Increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty of breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), impaired vision, fast heart beat, upset stomach, abnormal liver function*, hives (urticaria), medicine rash, inflammation of the tendons, flu-like illness (for example muscle pain, feeling generally unwell), decreased haemoglobin (a blood protein), increased levels of creatinine phosphokinase in the blood.
* Most cases of abnormal liver function and liver disorder from post-marketing experience with telmisartan occurred in Japanese patients. Japanese patients are more likely to experience this side effect.
Amlodipine
In patients taking amlodipine alone the following additional side effects have been reported:
Medicinal product no longer authorised
Uncommon side effects (may affect up to 1 in 100 people):
Mood changes, impaired vision, ringing in the ears, shortness of breath, sneezing/running nose, change of bowel habit, hair loss, unusual bruising and bleeding (red blood cell damage), skin discolouration, increased sweating, difficulty passing urine, increased need to pass urine especially at night, enlarging of male breasts, pain, weight increased, weight decreased.
Rare side effects (may affect up to 1 in 1,000 people): Confusion.
Very rare side effects (may affect up to 1 in 10,000 people):
Reduced number of white blood cells (leucopenia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), excess sugar in blood , uncontrollable twitching or jerking movements, heart attack, irregular heart beat, inflammation of the blood vessels, inflamed pancreas, inflammation of the stomach lining (gastritis), inflammation of the liver, yellowing of the skin (jaundice), increased levels of hepatic enzymes with jaundice, rapid swelling of skin and mucosa (angioedema), severe skin reactions, hives (urticaria), severe allergic reactions with blistering eruptions of the skin and mucous membranes (exfoliative dermatitis, Stevens-Johnson-Syndrome), increased sensitivity of the skin to sun.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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 carton and blister after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from light and moisture. Remove your Onduarp tablet from the blister only directly prior to intake.
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.
The active substances are telmisartan and amlodipine.
Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as besylate).
The other ingredients are colloidal anhydrous silica, brilliant blue FCF (E 133), ferric oxide black (E172), ferric oxide yellow (E172), magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone K25, pregelatinized starch, sodium hydroxide, sorbitol (E420).
Onduarp 40 mg/5 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A1 and the company logo on the other side.
Medicinal product no longer authorised
Onduarp is available in a folding box containing 28 tablets in aluminium/aluminium blisters.
Boehringer Ingelheim International GmbH Binger Str. 173
D-55216 Ingelheim am Rhein Germany
Boehringer Ingelheim Pharma GmbH & Co. KG Binger Str. 173
D-55216 Ingelheim am Rhein Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
SCS Boehringer Ingelheim Comm.V Tél/Tel: +32 2 773 33 11
Boehringer Ingelheim RCV GmbH & Co KG Lietuvos filialas
Tel.: +370 37 473922
Бьорингер Ингелхайм РЦВ ГмбХ и Ко КГ -
клон България
Тел: +359 2 958 79 98
SCS Boehringer Ingelheim Comm.V Tél/Tel: +32 2 773 33 11
Boehringer Ingelheim spol. s r.o. Tel: +420 234 655 111
Boehringer Ingelheim RCV GmbH & Co KG Magyarországi Fióktelepe
Tel.: +36 1 299 89 00
Boehringer Ingelheim Danmark A/S Tlf: +45 39 15 88 88
Boehringer Ingelheim Ltd. Tel: +44 1344 424 600
Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 800 77 90 900
Boehringer Ingelheim b.v. Tel: +31 (0) 800 22 55 889
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Boehringer Ingelheim RCV GmbH & Co KG Eesti Filiaal
Tel: +372 612 8000
Boehringer Ingelheim Norway KS Tlf: +47 66 76 13 00
Boehringer Ingelheim Ellas A.E. Tηλ: +30 2 10 89 06 300
Boehringer Ingelheim RCV GmbH & Co KG Tel: +43 1 80 105-0
Boehringer Ingelheim España S.A. Tel: +34 93 404 51 00
Boehringer Ingelheim Sp.zo.o. Tel.: +48 22 699 0 699
Boehringer Ingelheim France S.A.S. Tél: +33 3 26 50 45 33
Boehringer Ingelheim, Lda. Tel: +351 21 313 53 00
Boehringer Ingelheim Zagreb d.o.o. Tel: +385 1 2444 600
Boehringer Ingelheim RCV GmbH & Co KG Viena - Sucursala Bucuresti
Tel: +40 21 302 2800
Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9620
Boehringer Ingelheim RCV GmbH & Co KG Podružnica Ljubljana
Tel: +386 1 586 40 00
Vistor hf.
Sími: +354 535 7000
Boehringer Ingelheim RCV GmbH & Co KG organizačná zložka
Tel: +421 2 5810 1211
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Boehringer Ingelheim Ellas A.E. Tηλ: +30 2 10 89 06 300
Boehringer Ingelheim AB Tel: +46 8 721 21 00
Boehringer Ingelheim RCV GmbH & Co KG Latvijas filiāle
Tel: +371 67 240 011
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