150 mg / 12.5 mg film-coated tablets 
irbesartan / hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What CoAprovel is and what it is used for 
2. What you need to know before taking CoAprovel 
3. How to take CoAprovel 
4. Possible side effects 
5. How to store CoAprovel 6. Contents of the pack 
and other ingredients information

1. 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 called angiotensin -II receptor antagonists. Angiotensin -II is a substance, which is produced in the body, and which binds to certain structures ( receptors ) in the blood vessels and causes them to contract. This leads to increased blood pressure. Irbesartan prevents the binding of angiotensin -II to these receptors, causing the blood vessels to relax and the blood pressure to drop. 
Hydrochlorothiazide belongs to a group of medicines (called thiazide diuretics) that increase urine excretion and thereby lower blood pressure. 
The two active substances in CoAprovel work together so that the blood pressure is lowered more than if the substances were given separately.

CoAprovel is used to treat high blood pressure, as treatment with irbesartan or hydrochlorothiazide alone has not provided adequate control of blood pressure.

2. What you need to know before you take CoAprovel

Do not take CoAprovel

  • if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6).
  • if you are allergic to hydrochlorothiazide or any of the other sulfonamide-based medicines
  • Pregnant women should not use CoAprovel during the last 6 months of pregnancy. (It is also good to avoid CoAprovel earlier in pregnancy, see section Pregnancy and breast-feeding).
  • if you have severe liver or kidney problems
  • if you have difficulty “throwing water”
  • if your doctor thinks you have a condition associated with persistent high calcium or low potassium levels in your blood
  • if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren

Warnings and cautions

Talk to your doctor before taking CoAprovel and if any of the following apply to you:

  • if you experience severe vomiting or diarrhea
  • if you suffer from kidney problems or have a kidney transplant
  • 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 )
  • if you suffer from primary aldosteronism (a condition associated with high production of the hormone et alaldosterone, which causes decreased secretion of sodium and in turn an increase in blood pressure )
  • if you are taking any of the following medicines used to treat high blood pressure:
    • an ACE inhibitor (eg enalapril, lisinopril, ramipril), especially if you have diabetes-related kidney problems.
    • aliskiren.
  • if you have had skin cancer or if you get an unforeseen skin change during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while taking CoAprovel

Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals.

See also the information under the heading “Do not take CoAprovel”.

If you think you may be pregnant or become pregnant during treatment, consult your doctor. CoAprovel is not recommended during early pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects, see section Pregnancy, breast-feeding and fertility.

You should also tell your doctor:

  • if you are on a low salt diet
  • if you have symptoms such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle aches or cramps, nausea, vomiting, or an abnormally fast heart rate which may indicate an excessive effect of hydrochlorothiazide(found in CoAprovel)
  • if you notice increased sun sensitivity of the skin, which burns (with redness, itching, swelling, blistering) faster than usual
  • if you are going to have surgery or get anesthesia
  • if you experience impaired vision or pain in one or both of your eyes while taking CoAprovel. This may be a sign of choroidal effusion or increased pressure in your eyes ( glaucoma ) and may occur within hours or up to a week after taking CoAprovel. This can lead to permanent vision loss if left untreated. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this. You should then end treatment with CoAprovel and see a doctor immediately.

Hydrochlorothiazide contained in this medicine may give a positive result in doping tests.

Children and young people

CoAprovel should not be given to children or adolescents (under 18 years of age).

Other medicines and CoAprovel

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Diuretics such as hydrochlorothiazide in CoAprovel may affect other medicines. Medicines containing lithium should not be taken with CoAprovel without the careful supervision of your doctor.

Your doctor may need to change your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take CoAprovel” and “Warnings and precautions”).

You may need to have blood tests done if you are taking:

  • potassium supplement
  • salt substitute containing potassium
  • potassium-sparing medicines or other diuretic drugs
  • certain laxatives
  • drugs for the treatment of gout
  • therapeutic vitamin D supplementation
  • drugs to control heart rhythm
  • drugs for diabetes (tablets or insulin )
  • carbamazepine (a medicine used to treat epilepsy )

It is also important to tell your doctor if you are taking other medicines to lower blood pressure, steroids, medicines to treat cancer, painkillers, anti-inflammatory drugs or cholestyramine, and colestipol resins to lower cholesterol levels in the blood.

CoAprovel with food and drink

CoAprovel can be taken with or without food.

Due to the hydrochlorothiazide content of CoAprovel, if you drink alcohol during treatment with this medicine, you may have an increased feeling of dizziness when standing up, especially when standing up from a sitting position.

Pregnancy, breastfeeding, and fertility

Pregnancy 
If you think you may be pregnant or become pregnant during treatment, consult your doctor. Usually, your doctor suggests that you stop taking CoAprovel before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. CoAprovel should not be used during early pregnancy and should not be used during the last 6 months of pregnancy, as it may cause birth defects.

Breast-feeding 
Tell your doctor if you are breast-feeding or planning to start breast-feeding. CoAprovel is not recommended for breastfeeding and your doctor may choose another treatment for you if you want to breast-feed your baby, especially if your baby is newborn or born prematurely.

Driving and using machines

CoAprovel is unlikely to affect your ability to drive or use machines. Occasionally, however, dizziness or fatigue may occur during the treatment of high blood pressure. If you experience this, talk to your doctor before driving or using machines.

CoAprovel contains lactose

If you have been told by your doctor that you have an intolerance to some sugars (eg lactose ), contact your doctor before taking this medicine.

3. How to take CoAprovel

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Posology The 
the recommended dose of CoAprovel is one or two tablets daily. CoAprovel is usually prescribed by your doctor when previous treatment for high blood pressure did not lower your blood pressure sufficiently. Your doctor will tell you how to switch from the previous treatment to CoAprovel.

Intake 
CoAprovel is used orally. Swallow the tablets with a sufficient amount of liquid (eg a glass of water). You can take CoAprovel with or without food. You should try to take the daily dose at about the same time each day. It is important that you continue to take CoAprovel until your doctor tells you otherwise.

Maximum reduction in blood pressure should be achieved 6-8 weeks after starting treatment.

If you take more CoAprovel then you should

If you accidentally take too many tablets, contact your doctor immediately.

Children should not take CoAprovel 
CoAprovel should not be given to children under 18 years of age. Contact your doctor immediately if a child swallows any tablets.

If you forget to take CoAprovel

If you accidentally skip a daily dose, just take the next dose normally. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. 
Some side effects can be serious and may require medical treatment.

Rare cases of allergic skin reactions (skin rash, hives ) as well as local swelling of the face, lips, and/or tongue have been reported in patients treated with irbesartan. If you get any of the above symptoms or become short of breath, stop taking CoAprovel and contact your doctor immediately.

The frequency of side effects listed below is defined according to the following convention: 
Common: may affect up to 1 in 10 patients 
Uncommon: may affect up to 1 in 100 patients

Adverse reactions reported in clinical trials in patients treated with CoAprovel were:

Common side effects are (may affect up to 1 in 10)

  • nausea/vomiting
  • altered urination
  • fatigue
  • dizziness (also when getting up from a lying or sitting position)
  • Blood tests may show elevated levels of an enzyme that measures muscle and heart function (creatine kinase) or elevated levels of substances that measure kidney function (s- urea, creatinine ).

If any of these side effects get you down, talk to your doctor.

Less common side effects are (may affect up to 1 in 100 patients)

  • diarrhea
  • low blood pressure
  • fainting sensation
  • palpitation
  • redness
  • swelling
  • impaired sexual ability
  • Blood tests may show decreased levels of potassium and sodium in the blood

If any of these side effects get you down, talk to your doctor.

Side effects are reported after CoAprovel has entered the market

Some side effects have been reported since CoAprovel hit the market. Side effects without known frequency are: headache, ringing in the ears, cough, taste changes, indigestion, joint and muscle pain, impaired liver function and impaired kidney function, increased levels of potassium in the blood, and allergic reactions such as skin rash, hives, swelling of the face, lips, mouth, tongue or throat. Jaundice (yellowing of the skin and/or whites of the eyes) has, as a less common side effect, also been reported.

As with all combinations of two active substances, side effects associated with each individual active substance cannot be ruled out.

Side effects are associated with irbesartan alone

In addition to the side effects described above, chest pain, severe allergic reactions (anaphylactic shock ) and decreased platelet count (a blood cell needed for the blood to coagulate) have also been reported.

Side effects associated with hydrochlorothiazide 
alone Loss of appetite; stomach upset; stomach cramps; constipation; jaundice (yellowing of the skin and / or whites of the eyes); inflammation of the pancreas characterized by severe pain in the upper abdomen, often with nausea and vomiting; sleep disorders; Depression; dimsyn; lack of white blood cells , which can lead to frequent infection , fever; decreased number of platelets (a blood cell needed for the blood to coagulate), decreased number of red blood cells ( anemia ) characterized by fatigue, headache, shortness of breath on exertion, dizziness and pallor; kidney disease; lung problems includingpneumonia or fluid accumulation in the lungs; increased skin sensitivity to the sun; inflammation of blood vessels; a skin disease characterized by the peeling of the skin on the whole body; cutaneous lupus erythematosus, which is identified by a skin rash that may occur on the face, neck and scalp; allergic reactions; weakness and muscle twitching; altered heart rate; decreased blood pressure with altered posture; swelling of the salivary glands; high blood sugar levels; sugar in the urine; increased levels of certain types of blood fats; high uric acid levels in the blood, which can cause gout .

No known frequency (frequency can not be calculated from the available data): skin and lip cancer (non-melanoma skin cancer), decreased vision or pain in the eyes due to high pressure (possible signs of choroidal effusion or acute narrow-angle glaucoma ).

It is known that side effects associated with hydrochlorothiazide may increase with higher doses.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store CoAprovel

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 on the blister after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C.

Store in the original package. Moisture sensitive.

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. Contents of the packaging and other information

Content declaration

  • The active substances are irbesartan and hydrochlorothiazide . Each CoAprovel 150 mg / 12.5 mg film-coated tablet contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide .
  • The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silica, magnesium stearate, titanium dioxide, macrogol 3000, red and yellow iron oxide, carnauba wax. See section 2 “CoAprovel contains lactose”.

What the medicine looks like and the contents of the pack

CoAprovel 150 mg / 12.5 mg film-coated tablet is peach-colored, biconvex, oval, with a heart embossed on one side and number 2875 engraved on the other side.

CoAprovel 150 mg / 12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 and 98 tablets. Single-dose packs (pressure packs) of 56 × 1 tablets are also available for hospital use.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

sanofi-aventis groupe 
54, rue La Boétie, 
F-75008 Paris – France

Manufacturer 
SANOFI WINTHROP INDUSTRIE 
1, rue de la Vierge 
Ambarès & Lagrave 
F-33565 Carbon Blanc Cedex – France

CHINON PRIVATE CO. LTD. 
Levi u.5. 
2112 Veresegyház – Hungary

SANOFI WINTHROP INDUSTRY 
30-36 Avenue Gustave Eiffel 
37100 Tours – France

Sanofi-Aventis, SA

Ctra. C-35 (La Batlloria-Hostalric), km. 63.09

17404 Riells and Viabrea (Girona)

Spain

Further information on this medicine can be obtained from the representative of the marketing authorization holder: Show larger

Belgium / Belgique / BelgienSanofi BelgiumTel: +32 (0) 2 710 54 00
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DenmarkSanofi A / STel: +45 45 16 70 00
MaltaSanofi SpATel: +39 02 39394275
GermanySanofi-Aventis Deutschland GmbHTel: 0800 52 52 010Tel. from abroad: +49 69 305 21 131
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Spainsanofi-aventis, SATel: +34 93 485 94 00
Polandsanofi-aventis Sp. z ooTel .: +48 22 280 00 00
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Irelandsanofi-aventis Ireland Ltd. T / A SANOFITel: +353 (0) 1 403 56 00
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IcelandVistor hf.Phone: +354 535 7000
Slovak Republicsanofi-aventis Pharma Slovakia sroTel: +421 2 33 100 100
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Muhammad Nadeem

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