150 mg / 12.5 mg, 300 mg / 12.5 mg, 300 mg / 25 mg film-coated tablets
irbesartan / hydrochlorothiazide

What Irbesartan / Hydrochlorothiazide Actavis is and what it is used for

Irbesartan / Hydrochlorothiazide Actavis 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 constrict. 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 Irbesartan / Hydrochlorothiazide Actavis work together to lower blood pressure more than if you have only given one of the substances.

Irbesartan / Hydrochlorothiazide Actavis is used for treating high blood pressure, as treatment with irbesartan or hydrochlorothiazide alone has not resulted in a sufficient reduction in blood pressure.

Irbesartan and the hydrochlorothiazide contained in Irbesartan / Hydrochlorothiazide Actavis may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Irbesartan / Hydrochlorothiazide Actavis

Do not take Irbesartan / Hydrochlorothiazide Actavis

  • if you are allergic to irbesartan, hydrochlorothiazide , any of the other ingredients of this medicine (listed in section 6) or any of the other sulfonamide-based medicines (ask your doctor or pharmacist if necessary).
  • if you are pregnant. Pregnant women should not use Irbesartan / Hydrochlorothiazide Actavis during the last 6 months of pregnancy . (Even earlier in pregnancy, it is good to avoid Irbesartan / Hydrochlorothiazide Actavis, see Warnings and Precautions and 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 Irbesartan / Hydrochlorothiazide Actavis

  • if you experience severe vomiting or diarrhea
  • if you have kidney problems or have a kidney transplant
  • if you have heart problems
  • if you have liver problems
  • if you have diabetes
  • if you have lupus erythematosus (also known as lupus or SLE )
  • if you have primary aldosteronism (a condition associated with high production of the hormone et aldosterone , which causes decreased sodium secretion 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 using Irbesartan / Hydrochlorothiazide Actavis.

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 Irbesartan / Hydrochlorothiazide Actavis”.

If you think you may be pregnant or become pregnant during treatment, consult your doctor. Irbesartan / Hydrochlorothiazide Actavis 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 Pregnancy and breast-feeding.

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 Irbesartan / Hydrochlorothiazide Actavis)
  • 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 eye pain . This may be a symptom of fluid accumulation in the eye (between the choroid and retina) or an increase in the pressure in your eye and may occur within hours to weeks after taking Irbesartan / Hydrochlorothiazide Actavis. This can lead to permanent vision loss, if left untreated. If you have previously had a penicillin or sulfonamide allergy, you may be at greater risk of developing this.

Children and young people

Irbesartan / Hydrochlorothiazide Actavis should not be used in children or adolescents (under 18 years of age).

Other medicines and Irbesartan / Hydrochlorothiazide Actavis

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

Diuretics such as hydrochlorothiazide in Irbesartan / Hydrochlorothiazide Actavis may affect other medicines. Medicines containing lithium should not be taken with Irbesartan / Hydrochlorothiazide Actavis without your doctor’s advice.

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
  • vitamin D supplement
  • medications to control heart rhythm
  • medicines for diabetes (tablets or insulin )
  • carbamazepine (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, cholestyramine, and cholestipol resins to lower blood cholesterol levels, non-depolarizing muscle relaxants (eg tubocurarine), anticholinergics (eg atropine, limited) or amantadine.

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 Irbesartan / Hydrochlorothiazide Actavis” and “Warnings and precautions”).

Irbesartan / Hydrochlorothiazide Actavis with food, drink and alcohol

Irbesartan / Hydrochlorothiazide Actavis can be taken with or without food.

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

Pregnancy and breastfeeding

Pregnancy

If you think you may be pregnant or become pregnant during treatment, consult your doctor. Your doctor will usually suggest that you stop taking Irbesartan / Hydrochlorothiazide Actavis before pregnancy, or as soon as you know you are pregnant and will recommend another medicine for you instead. Irbesartan / Hydrochlorothiazide Actavis 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 breastfeeding or planning to start breastfeeding. Irbesartan / Hydrochlorothiazide Actavis is not recommended for breastfeeding and your doctor may choose another treatment for you if you want to breastfeed your baby, especially if your baby is newborn or born prematurely.

If you are pregnant or breastfeeding if you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Irbesartan / Hydrochlorothiazide Actavis contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘sodium-free.

How to use Irbesartan / Hydrochlorothiazide Actavis

Use for children and adolescents

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

Dosage

The recommended dose of Irbesartan / Hydrochlorothiazide Actavis is one tablet daily. Irbesartan / Hydrochlorothiazide Actavis 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 Irbesartan / Hydrochlorothiazide Actavis.

Intake

Irbesartan / Hydrochlorothiazide Actavis tablets should be swallowed with a sufficient amount of liquid (eg a glass of water). You can take Irbesartan / Hydrochlorothiazide Actavis with or without food. You should try to take the daily dose at about the same time each day. You must continue to take Irbesartan / Hydrochlorothiazide Actavis until your doctor tells you otherwise.

The maximum lowering of blood pressure should be achieved 6-8 weeks after starting treatment.

Use for children and adolescents

Irbesartan / Hydrochlorothiazide Actavis should not be used in children and adolescents below 18 years. Contact your doctor immediately if a child swallows any tablets.

If you use more Irbesartan / Hydrochlorothiazide Actavis than you should  

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Irbesartan / Hydrochlorothiazide Actavis

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 taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Irbesartan / Hydrochlorothiazide Actavis and contact your doctor immediately.

Adverse reactions reported in clinical trials in patients treated with Irbesartan / Hydrochlorothiazide Actavis were:

Common (may affect up to 1 in 10 people):

  • nausea / vomiting,
  • abnormal 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 ).

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

  • diarrhea,
  • low blood pressure ,
  • fainting,
  • palpitation,
  • redness ,
  • swelling,
  • impaired sexual ability,
  • blood tests may show decreased levels of potassium and sodium in the blood,
  • yellowing of the skin and / or of the whites of the eyes (jaundice)

Has been reported (occurs in unknown number of users):

  • headache,
  • ringing in the ears,
  • cough,
  • taste changes,
  • indigestion,
  • joint and muscle pain,
  • impaired liver function,
  • inflammation of the liver which causes yellowing of the skin or eyes,
  • renal impairment,
  • kidney failure ,
  • increased levels of potassium in the blood and
  • allergic reactions such as skin rash, hives, swelling of the face, lips, mouth, tongue or throat.

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

The adverse event is as associated with irbesartan alone

In addition to the side effects described above, the following side effects have also been reported:

  • Uncommon (may affect up to 1 in 100 people): chest pain.
  • Has been reported (occurs in an unknown number of users): decreased platelet count (a blood cell needed for blood to coagulate), severe allergic reactions (anaphylactic shock )

Side effects are associated with hydrochlorothiazide alone

Has been reported (occurs in unknown number of users): 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; yellow vision, 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 during 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 levels of uric acid in the blood, which can cause gout; height dizziness, numbness, tingling or ant crawling, dizziness, restlessness, electrolyte disturbances (including hypokalaemia andhyponatremia ), changes in vision or pain in one or both eyes (possible signs of fluid accumulation in the eye (between the choroid and retina) or acute narrow-angle glaucoma ), skin and lip cancer (non- melanoma skin cancer).

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 also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Irbesartan / Hydrochlorothiazide Actavis

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 can, carton and blister after EXP. or EXP. The expiration date is the last day of the specified month.

Blister: Do not store above 25 ° C.

Jar: No special storage instructions.

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 film-coated tablet contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide , 300 mg irbesartan and 12.5 mg hydrochlorothiazide and 300 mg irbesartan and 25 mg hydrochlorothiazide, respectively .
  • Other ingredients are:Tablet core: mannitol (E 421, povidone (K29-32 or equivalent), microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.Film coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172) (only for Irbesartan / Hydrochlorothiazide Actavis 300 mg / 12.5 mg and Irbesartan / Hydrochlorothiazide Actavis 300 mg / 25 mg film-coated tablets).

What the medicine looks like and contents of the pack

Irbesartan / Hydrochlorothiazide Actavis 150 mg / 12.5 mg film-coated tablets:

Pink, biconvex, oval shaped, 6.5 x 12.7 mm film-coated tablet with H engraved on one side and I on the other side.

Irbesartan / Hydrochlorothiazide Actavis 300 mg / 12.5 mg film-coated tablets:

Pink, biconvex, oval shaped, 8.2 x 16.0 mm film-coated tablet with H engraved on one side and I on the other side.

Irbesartan / Hydrochlorothiazide Actavis 300 mg / 25 mg film-coated tablets:

Dark pink, biconvex, oval, 8.2 x 16.0 mm film-coated tablet with H engraved on one side and I on the other side.

Blisters: 14, 28, 30, 56, 60, 98 and 100 film-coated tablets

Jars: 100, 250 and 500 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjordur

Iceland

Muhammad Nadeem

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