The wording of leaflets is regularly updated. This electronic text is the most up-to-date version and may differ from the leaflet in your pack. If you have any questions about the information provided, please ask your doctor or pharmacist.
CoAprovel 150/12.5mg film-coated tablets
CoAprovel 300/12.5mg film-coated tablets
CoAprovel 300/25mg film-coated tablets
Irbesartan/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 further questions, ask your doctor or your 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 CoAprovel is and what it is used for
- 2. Before you take CoAprovel
- 3. How to take CoAprovel
- 4. Possible side effects
- 5. How to store CoAprovel
- 6. Further information
What Coaprovel Is And What It Is Used For
CoAprovel is a combination of two active substances, irbesartan and hydrochlorothiazide. Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Hydrochlorothiazide is one of a group of medicines (called thiazide diuretics) that causes increased urine output and so causes a lowering of blood pressure.
The two active ingredients in CoAprovel work together to lower blood pressure further than if either was given alone.
CoAprovel is used in the treatment of high blood pressure (essential hypertension), when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.
Before You Take Coaprovel
Do not take CoAprovel
- if you are allergic (hypersensitive) to irbesartan and hydrochlorothiazide or any of the other ingredients included in CoAprovel or to sulphonamide-derived medicines
- if you are in the second or third trimester of pregnancy
- if you are breast-feeding
- if you have severe liver or kidney problems
- if you have difficulty in producing urine
- if you have a condition which is associated with persistently high calcium or low potassium levels in your blood
CoAprovel should not be given to children and adolescents (< 18 years)
Take special care with CoAprovel
- if you suffer from excessive vomiting or diarrhoea
- if you suffer from kidney problems, including kidney transplantation
- if you suffer from heart problems
- if you suffer from liver problems
- if you suffer from diabetes
- if you suffer from lupus erythematosus (also known as lupus or SLE)
You should also tell your doctor:
- if you are on a low-salt diet
- if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in CoAprovel)
- if you are to undergo any surgery or receive anaesthetics
Hydrochlorothiazide contained in this medication could produce a positive result in an anti-doping test.
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.
Diuretic agents such as the hydrochlorothiazide contained in CoAprovel may interact with other medicines. Preparations containing lithium should not be taken with CoAprovel without close supervision by your doctor. Special precautionary measures (e.g. blood tests) may be appropriate if you take potassium supplements, potassium-containing salt substitutes or potassium sparing medicines, other diuretics (water tablets), some laxatives, medicines for the treatment of gout, therapeutic vitamin D supplements, medicines to control heart rhythm or for diabetes (oral agents or insulins). It is also important for your doctor to know if you are taking other medicines to reduce your blood pressure, steroids, medicines to treat cancer, pain killers or arthritis medicines.
Taking CoAprovel with food and drink
CoAprovel can be taken with or without food
Pregnancy and breastfeeding
Tell your doctor before taking CoAprovel if you are pregnant, think you may be pregnant, or are planning to be pregnant. It is preferable not to use CoAprovel in the first trimester of pregnancy. If you become pregnant while on CoAprovel treatment, refer to your doctor without delay. CoAprovel must not be taken during the second or third trimester of pregnancy, or while breast-feeding (see "Do not take CoAprovel"). A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy.
Driving and using machines:
No studies on the effects on the ability to drive and use machines has been performed. CoAprovel is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, you should consult your doctor before attempting such activities.
Important information about some of the ingredients of CoAprovel
CoAprovel contains lactose monohydrate (see "further information"). If you have been told by your doctor that you may have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.
How To Take Coaprovel
Always take CoAprovel exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.
CoAprovel will usually be prescribed by your doctor when your previous treatment for high blood pressure did not provide appropriate blood pressure reduction. Your doctor will instruct you how to switch from the previous treatment to CoAprovel.
CoAprovel 150 mg/12.5 mg film-coated tablets:
The usual dose of CoAprovel 150 mg/12.5 mg film-coated tablets is one or two tablets a day. If your doctor has prescribed for you to take two tablets a day, you should take two tablets from the blisters indicating the same day (e.g. when you take your medicine on Monday, take the two tablets from the blister indicating "Mon").
CoAprovel 300 mg/12.5 mg and 300 mg/25 mg film-coated tablets:
The usual dose is one tablet a day.
The maximal blood pressure lowering effect should be reached 6-8 weeks after beginning treatment.
Kind of administration
For oral use
The tablets should be swallowed with a sufficient amount of fluid (e.g. one glass of water). You can take CoAprovel with or without food. You should try to take your daily dose at about the same time each day. It is important that you continue to take CoAprovel until your doctor tells you otherwise.
If you take more CoAprovel than you should
If you accidentally take too many tablets, or a child swallows some, contact your doctor immediately.
If you forget to take CoAprovel
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for forgotten individual doses.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, CoAprovel may cause side effects, although not everybody gets them.
Some of these effects may be serious and may require medical attention.
- The frequency of the side effects listed below is defined using the following convention:
- Common: at least 1 in 100 and less than 1 in 10 patients
- Uncommon: at least 1 in 1000 and less than 1 in 100 patients
- Side effects reported in clinical studies for patients treated with CoAprovel were:
- Common: nausea/vomiting, abnormal urination, fatigue and dizziness (including when getting up from a lying or sitting position).
- Uncommon: diarrhoea, low blood pressure, fainting, heart rate increased, flushing, swelling and sexual dysfunction (problems with sexual performance).
- In addition your doctor may identify abnormal changes in your blood components:
- Common: blood urea nitrogen increased, creatinine increased and creatine kinase increased.
- Uncommon: serum potassium decreased and sodium decreased.
Occasional side effects reported since the marketing of CoAprovel are: headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, abnormal liver function and impaired renal function.
As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you think you are developing such a reaction or get short of breath stop taking CoAprovel and seek immediate medical attention.
As for any combination of two active substances, side effects associated with each individual component cannot be excluded. In patients taking irbesartan alone, in addition to the side effects listed above, chest pain has also been reported.
The other component of CoAprovel (hydrochlorothiazide) has been associated rarely with other more serious side effects mainly affecting the blood, the skin or the kidneys. While this was not observed with CoAprovel, occurrence of such side effects cannot be excluded.
It is known that side effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.
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.
How To Store Coaprovel
Keep out of the reach and sight of children.
Do not use CoAprovel after the expiry date which is stated on the carton and on the blister after "EXP". The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
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.
Further INFORMATION
What CoAprovel contains
- The active substances are irbesartan and hydrochlorothiazide.
- Each film-coated tablet of CoAprovel 150 mg/12.5 mg contains 150mg irbesartan and 12.5 mg hydrochlorothiazide
- Each film-coated tablet of CoAprovel 300 mg/12.5 mg contains 300mg irbesartan and 12.5 mg hydrochlorothiazide
- Each film-coated tablet of CoAprovel 300 mg/25 mg contains 300mg irbesartan and 25 mg hydrochlorothiazide.
- The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, red and yellow ferric oxides and carnauba wax.
- The CoAprovel 300 mg/25 mg also contains pregelatinized starch and black ferric oxide.
What CoAprovel looks like and contents of the pack
CoAprovel 150 mg/12.5 mg film-coated tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2875 engraved on the other side.
CoAprovel 300 mg/12.5 mg film-coated tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2876 engraved on the other side.
CoAprovel 300 mg/25 mg film-coated tablets are pink, biconvex, oval-shaped, with a heart debossed on one side and the number 2788 engraved on the other side.
CoAprovel film-coated tablets are supplied in blister packs of 28 film-coated tablets.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
United Kingdom
This leaflet was last approved in January 2007
Detailed information on this medicine is available on the European Medicines Agency (EMEA) webside: http://www.emea.europa.eu/
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