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

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

Irbesartan / Hydrochlorothiazide Stada 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 the excretion of urine and thereby lower blood pressure.

The two active substances in Irbesartan / Hydrochlorothiazide Stada work together so that blood pressure is lowered more than if the substances were given separately.

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

Irbesartan/hydrochlorothiazide contained in Irbesartan / Hydrochlorothiazide Stada may also be approved for the treatment of other conditions not mentioned in this product information. 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 STADA

Do not take Irbesartan / Hydrochlorothiazide STADA

  • 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 Irbesartan / Hydrochlorothiazide Stada during the last 6 months of pregnancy. (Even earlier in pregnancy, it is good to avoid Irbesartan / Hydrochlorothiazide Stada, see 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 mellitus or renal impairment and you are being treated with aliskiren (another medicine to treat high blood pressure )

Warnings and cautions

Talk to your doctor or pharmacist before taking Irbesartan / Hydrochlorothiazide Stada 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 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.
  • Your doctor may need to check your kidney function, blood pressure , and the amount of electrolytes (such as potassium ) in your blood at regular intervals.
  • 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 Irbesartan / Hydrochlorothiazide Stada.

If you think you are pregnant or planning to become pregnant during treatment, contact your doctor. Irbesartan / Hydrochlorothiazide Stada 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, breastfeeding, 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 Irbesartan / Hydrochlorothiazide Stada)
  • 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 get s changes or pain in one or both of your eyes . This may be a symptom of fluid accumulation in the eye (between the choroid and retina) or an increase in pressure in the eye and may occur within a few hours to weeks after taking Irbesartan / Hydrochlorothiazide. This can lead to permanent visual impairment, if left untreated. If you have previously had a penicillin or sulfonamide allergy, you may be at higher risk of developing this.

Children and young people

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

Other medicines and Irbesartan / Hydrochlorothiazide STADA

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 Stada may affect other medicines. Medicines containing lithium should not be taken with Irbesartan / Hydrochlorothiazide Stada without the careful supervision of your doctor.

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

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

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

  • potassium supplement
  • salt substitute containing potassium
  • potassium sparing drugs 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 your blood pressure, steroids, medicines to treat cancer, painkillers, anti-inflammatory drugs or cholestyramine, and cholestipol resins to lower your blood cholesterol levels.

Irbesartan / Hydrochlorothiazide STADA with food and drink

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

Due to the hydrochlorothiazide content of Irbesartan / Hydrochlorothiazide Stada, 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, breastfeeding and fertility

Pregnancy

If you think you are pregnant or planning to become pregnant during treatment, contact your doctor. Your doctor will usually suggest that you stop taking Irbesartan / Hydrochlorothiazide Stada before pregnancy or as soon as you know you are pregnant and then recommend another medicine to you. Irbesartan / Hydrochlorothiazide Stada should not be used during 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 Stada 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 premature.

Driving and using machines

No studies have been performed on the ability to drive or use machines. Irbesartan / Hydrochlorothiazide Stada 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 increased 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 STADA contains lactose and sodium

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.

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free. next to “sodium-free”.

How to use Irbesartan / Hydrochlorothiazide STADA

Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

Dosage

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

The recommended dose of Irbesartan / Hydrochlorothiazide Stada is one or two tablets daily. Irbesartan / Hydrochlorothiazide Stada 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 Stada.

Irbesartan / Hydrochlorothiazide Stada 300 mg / 12.5 mg film-coated tablets and Irbesartan / Hydrochlorothiazide Stada 300 mg / 25 mg film-coated tablets:

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

Intake

Irbesartan / Hydrochlorothiazide Stada should be swallowed . Swallow the tablets with a sufficient amount of liquid (eg a glass of water). You can take Irbesartan / Hydrochlorothiazide Stada 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 Irbesartan / Hydrochlorothiazide Stada until your doctor tells you otherwise.

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

Children should not take Irbesartan / Hydrochlorothiazide STADA

Irbesartan / Hydrochlorothiazide Stada should not be used in children below 18 years of age. Contact your doctor immediately if a child swallows any tablets.

If you take more Irbesartan / Hydrochlorothiazide STADA 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 take Irbesartan / Hydrochlorothiazide STADA

If you accidentally skip a daily dose , just take the next dose normally. Do not take a double dose

to compensate for missed 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 ) and 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 Irbesartan / Hydrochlorothiazide Stada and contact your doctor immediately.

Adverse reactions reported in clinical trials in patients treated with Irbesartan / Hydrochlorothiazide Stada 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 gets you down , tell your doctor.

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

  • 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 gets you down , talk to your doctor.

Adverse reactions have been reported after the introduction of irbesartan / hydrochlorothiazide

Some side effects have been reported since the introduction of irbesartan / hydrochlorothiazide. 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 irbersartan alone

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

Side effects associated with hydrochlorothiazide alone (reported: occurs in an 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; seam disorders; Depression; impaired vision or pain in the eyes due to high pressure (possible signs of fluid accumulation in the eye (between the choroid and retina) or acute narrow-angle glaucoma ), 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 including pneumonia 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, 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 STADA

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 expiration date is the last day of the specified month.

Do not store above 30 ° C.

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 .

Irbesartan / Hydrochlorothiazide Stada 150 mg / 12.5 mg film-coated tablets

Each tablet Irbesartan / Hydrochlorothiazide Stada 150 mg / 12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide .

Irbesartan / Hydrochlorothiazide Stada 300 mg / 12.5 mg film-coated tablets

Each tablet Irbesartan / Hydrochlorothiazide Stada 300 mg / 12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide .

Irbesartan / Hydrochlorothiazide Stada 300 mg / 25 mg film-coated tablets

Each tablet Irbesartan / Hydrochlorothiazide Stada 300 mg / 25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide .

The other ingredients are lactose monohydrate , pregelatinised maize starch, copovidone, croscarmellose sodium (E468), colloidal anhydrous silica (E551), magnesium stearate (E470b), hypromellose (E464), titanium dioxide (E171), talc, yellow17, nitrous oxide (E172), black iron oxide (E172).

What the medicine looks like and contents of the pack

Irbesartan / Hydrochlorothiazide Stada 150 mg / 12.5 mg film-coated tablets

Irbesartan / Hydrochlorothiazide Stada 150 mg / 12.5 mg film-coated tablets are pink, oblong, biconvex film-coated tablets.

Irbesartan / Hydrochlorothiazide Stada 300 mg / 12.5 mg film-coated tablets

Irbesartan / Hydrochlorothiazide Stada 300 mg / 12.5 mg film-coated tablets are pink, oblong, biconvex film-coated tablets.

Irbesartan / Hydrochlorothiazide Stada 300 mg / 25 mg film-coated tablets

Irbesartan / Hydrochlorothiazide Stada 300 mg / 25 mg film-coated tablets are red, oblong, biconvex film-coated tablets.

Irbesartan / Hydrochlorothiazide Stada 150 mg / 12.5 mg film-coated tablets

Pack sizes: 7, 10, 14, 28, 30, 50, 56, 90, 98 and 100 film-coated tablets.

Irbesartan / Hydrochlorothiazide Stada 300 mg / 12.5 mg film-coated tablets

Pack sizes: 7, 10, 14, 28, 30, 50, 56, 90, 98, 100, 126 and 154 film-coated tablets.

Irbesartan / Hydrochlorothiazide Stada 300 mg / 25 mg film-coated tablets

Pack sizes: 7, 10, 14, 28, 30, 50, 56, 90, 98, 100, 126 and 154 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastraße 2-18

61118 Bad Vilbel

Germany

Local representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev

Denmark

Muhammad Nadeem

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