Ipreziv
azilsartan medoxomil
azilsartan medoxomil
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
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 Ipreziv is and what it is used for
What do you need to know before you take Ipreziv
How to take Ipreziv
Possible side effects
How to store Ipreziv
Medicinal product no longer authorised
Contents of the pack and other information
Ipreziv contains an active substance called azilsartan medoxomil and belongs to a class of medicines called angiotensin II receptor antagonists (AIIRAs). Angiotensin II is a substance which occurs naturally in the body and which causes the blood vessels to tighten, therefore increasing your blood pressure. Ipreziv blocks this effect so that the blood vessels relax, which helps lower your blood pressure.
This medicine is used for treating high blood pressure (essential hypertension) in adult patients (over 18 years of age).
are allergic (hypersensitive) to azilsartan medoxomil or any of the other ingredients of Ipreziv (see section 6).
are more than 3 months pregnant. (It is also better to avoid Ipreziv in early pregnancy - see pregnancy section).
have diabetes mellitus or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Before you take, or whilst you are taking Ipreziv, tell your doctor if you:
have kidney problems
are on dialysis or had a recent kidney transplant
have severe liver disease
have heart problems (including heart failure, recent heart attack)
have ever had a stroke
have low blood pressure or feel dizzy or lightheaded
are vomiting, have recently had severe vomiting, or have diarrhoea
have elevated levels of potassium in your blood
have a disease of the adrenal gland called primary hyperaldosteronism
have been told that you have a narrowing of the valves in your heart (called “aortic or mitral valve stenosis”) or that the thickness of your heart muscle is abnormally increased (called “obstructive hypertrophic cardiomyopathy”).
are taking any of the following medicines used to treat high blood pressure:
an ACE-inhibitor (for example enalapril, lisinopril, ramipril), 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.
See also information under the heading “Do not take Ipreziv”.
You must tell your doctor if you think you are (or might become) pregnant. Ipreziv 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).
As with all other angiotensin II receptor antagonist medicines, azilsartan medoxomil may be less effective in lowering the blood pressure in black patients.
Medicinal product no longer authorised
There is no experience with the use of Ipreziv in children or adolescents under 18 years of age. Therefore, Ipreziv should not be given to children or adolescents.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Ipreziv can affect the way some other medicines work and some medicines can have an effect on Ipreziv.
In particular, tell your doctor if you are taking any of the following medicines:
Lithium (a medicine for mental health problems)
Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, diclofenac or celecoxib (medicines to relieve pain and inflammation)
Aspirin (acetylsalicyclic acid) if taking more than 3 g per day (medicine to relieve pain and inflammation)
Medicines that increase the amount of potassium in your blood; these include potassium supplements, potassium-sparing medicines (certain ‘water tablets’) or salt substitutes containing potassium
Heparin (a medicine for thinning the blood)
Diuretics (water tablets)
Aliskiren or other medicines to lower your blood pressure (angiotensin converting enzyme inhibitor or angiotensin II receptor blocker, such as enalapril, lisinopril, ramipril or valsartan, telmisartan, irbesartan).
Your doctor may need to change your dose and/or to take other precautions if you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Ipreziv” and “Warnings and precautions”).
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally
advise you to stop taking Ipreziv before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Ipreziv.
Ipreziv 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.
Tell your doctor if you are breast-feeding or about to start breast-feeding. Ipreziv 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.
Ipreziv is unlikely to have an effect on driving or using machines. However some people may feel tired or dizzy when taking Ipreziv and if this happens to you, do not drive or use any tools or machines.
Always take Ipreziv exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. It is important to keep taking Ipreziv every day.
Ipreziv is for oral use. Take the tablet with plenty of water. You can take Ipreziv with or without food.
Medicinal product no longer authorised
The usual starting dose is 40 mg once a day. Your doctor may increase this dose to a maximum of 80 mg once a day depending on blood pressure response.
For patients such as the very elderly (75 years and above) your doctor may recommend a lower starting dose of 20 mg once a day.
If you suffer from mild or moderate liver disease your doctor may recommend a lower starting dose of 20 mg once a day.
For patients who recently have lost body fluids e.g. through vomiting or diarrhoea, or by taking water tablets, your doctor may recommend a lower starting dose of 20 mg once a day.
If you suffer from other coexisting illnesses such as severe kidney disease or heart failure your doctor will decide on the most appropriate starting dose.
A reduction in your blood pressure will be measureable within 2 weeks of initiation of treatment and the full effect of your dose will be observed by 4 weeks.
If you take too many tablets, or if someone else takes your medicine, contact your doctor immediately. You may feel faint or dizzy if you have taken more than you should.
Do not take a double dose to make up for a forgotten dose. Just take the next dose at the usual time.
If you stop taking Ipreziv, your blood pressure may increase again. Therefore do not stop taking Ipreziv without first talking to your doctor about alternative treatment options.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, Ipreziv can cause side effects, although not everybody gets them.
Difficulties in breathing, or swallowing, or swelling of the face, lips, tongue and/or throat
(angioedema)
Itching of the skin with raised lumps.
Other possible side effects include:
Dizziness
Diarrhoea
Increased blood creatine phosphokinase (an indicator of muscle damage).
Low blood pressure, which may make you feel faint or dizzy
Feeling tired
Swelling of the hands, ankles or feet (peripheral oedema)
Skin rash and itching
Nausea
Muscle spasms
Increased serum creatinine in the blood (an indicator of kidney function)
Increased uric acid in the blood (an indicator of kidney function).
Medicinal product no longer authorised
Changes in blood test results including decreased levels of a protein in the red blood cells (haemoglobin).
When Ipreziv is taken with chlortalidone (a water tablet), higher levels of certain chemicals in the blood (such as creatinine), which are indicators of kidney function, have been seen commonly (in less than 1 in 10 users), and low blood pressure is also common.
Swelling of the hands, ankles or feet is more common (in less than 1 in 10 users) when Ipreziv is taken with amlodipine (a calcium channel blocker for treating hypertension) than when Ipreziv is taken alone (less than 1 in 100 users). The frequency of this event is highest when amlodipine is taken alone.
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.
Keep out of the reach and sight of children.
Do not use Ipreziv after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month.
Store Ipreziv in the original package in order to protect it from light and moisture. This medicine does not require any special temperature storage conditions.
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.
The active substance is azilsartan medoxomil (as potassium) either 20 mg, 40 mg or 80 mg
The other ingredients are mannitol, fumaric acid, sodium hydroxide, hydroxypropylcellulose, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate.
Ipreziv are white round tablets debossed “ASL” on one side and either “20”, “40” or “80” on the other.
Ipreziv is provided in blister packs with each blister pack having either 14 tablets or 15 tablets within cartons containing:
14, 28, 30, 56, 90 or 98 tablets for 20 mg tablets
14, 28, 30, 56, 90 or 98 tablets for 40 mg tablets
14, 28, 30, 56, 90 or 98 tablets for 80 mg tablets Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Medicinal product no longer authorised
Takeda Pharma A/S, Dybendal Alle 10, 2630 Taastrup, Denmark Manufacturer:
Takeda Ireland Limited, Bray Business Park, Kilruddery, Co. Wicklow, Ireland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Takeda Global R & D Centre (Europe) Tel: +44 (0) 203 116 8000
Takeda Global R & D Centre (Europe) Tél/Tel: +44 (0) 203 116 8000
Takeda Belgium Tél/Tel: +32 2 464 06 11
Takeda Global R & D Centre (Europe) Tél/Tel: +44 (0) 203 116 8000
Takeda Global R & D Centre (Europe) Tél/Tel: +44 (0) 203 116 8000
Takeda Pharmaceuticals Nordics AB Tlf: +46 (0) 8 5861 3380
Takeda Italia Farmaceutici SpA Tel: +39 06 5026 01
Takeda GmbH
Tel: 0800 825 3325
Takeda Nederland bv Tel: +31 (0) 23 566 8777
Takeda Global R & D Centre (Europe) Tel: +44 0203 116 8000
Takeda Pharmaceuticals Nordics AB Tlf: + 46 (0) 8 5861 3380
Takeda Global R & D Centre (Europe) Τηλ: +44 (0) 203 116 8000
Takeda Pharma Ges m.b.H Tel: +43 (1) 524 40 64
Takeda Farmacéutica España Tel: +34 93 184 5730
Takeda Global R & D Centre (Europe) Tel: +44 (0) 203 116 8000
Laboratoires Takeda
Tél: +33 (0) 1 46 25 16 16
Takeda - Farmacêuticos Portugal Tel: +351 21 464 32 22
Takeda Pharmaceuticals Croatia d.o.o. Tel: +385 1 377 88 96
Takeda Global R & D Centre (Europe) Tel: +44 (0) 203 116 8000
Takeda UK Ltd
Tel: +44 (0) 1628 537 900
Takeda Global R & D Centre (Europe) Tel: +44 (0) 203 116 8000
Medicinal product no longer authorised
Takeda Pharmaceuticals Nordics AB Sími: +46 (0) 8 5052 1105
Takeda Global R & D Centre (Europe) Tel: +44 (0) 203 116 8000
Takeda Italia Farmaceutici SpA Tel: +39 06 5026 01
Takeda Pharmaceuticals Nordics AB Puh/Tel: +46 (0) 8 5052 1105
Takeda Global R & D Centre (Europe) Τηλ: +44 (0) 203 116 8000
Takeda Pharmaceuticals Nordics AB Tel: + 46 (0) 8 5861 3380
Takeda Global R & D Centre (Europe) Tel: +44 (0) 203 116 8000
Takeda UK Ltd
Tel: +44 (0) 1628 537 900