150 mg / 12.5 mg and 300 mg / 25 mg film-coated tablets
irbesartan / hydrochlorothiazide
What Irbesartan / Hydrochlorothiazide Sandoz is and what it is used for
Irbesartan / Hydrochlorothiazide Sandoz is a combination of two active substances, irbesartan and hydrochlorothiazide .
Irbesartan belongs to a group of medicines called angiotensin II receptor antagonists. These cause the blood vessels to relax and the blood pressure to drop.
Hydrochlorothiazide is a group of medicines called diuretics ( diuretic agents).
The two active substances in Irbesartan / Hydrochlorothiazide Sandoz work together to lower blood pressure more than if the substances were given separately.
Irbesartan / Hydrochlorothiazide Sandoz is used for treating high blood pressure, as treatment with irbesartan or hydrochlorothiazide alone has not provided adequate control of blood pressure.
Irbesartan/hydrochlorothiazide contained in Irbesartan / Hydrochlorothiazide Sandoz 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 take Irbesartan / Hydrochlorothiazide Sandoz
Do NOT take Irbesartan / Hydrochlorothiazide Sandoz if you:
- is allergic to irbesartan, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6)
- is allergic (hypersensitive) to substances derived from sulfonamides (eg other thiazides and certain antibiotics , such as trimethoprim sulfa, ask your doctor if you are unsure)
- is pregnant and the pregnancy has lasted for over three months (it is also better to avoid Irbesartan / Hydrochlorothiazide Sandoz during early pregnancy – see section “Pregnancy and breast-feeding”)
- has severe hepatic impairment
- have severe renal impairment or if your kidneys do not produce urine
- have any condition that causes persistent high calcium or low potassium in your blood
- have diabetes or renal impairment and are being treated with a blood pressure lowering medicine containing aliskiren
Children and young people
Irbesartan / Hydrochlorothiazide Sandoz must not be used in children and adolescents below 18 years.
Warnings and cautions
These tablets are generally not recommended if you:
- have primary aldosteronism (Conn’s syndrome), adrenal tumor that causes muscle weakness, strong thirst and frequent urination
- have problems with the liver or kidneys
- while using lithium for the treatment of mental illness (see also “Other medicines and Irbesartan / Hydrochlorothiazide Sandoz” below)
- take aliskiren , a medicine used to treat high blood pressure .
You must tell your doctor if you think you are (or might become) pregnant.
Irbesartan / Hydrochlorothiazide Sandoz is not recommended during early pregnancy and should not be used if you are pregnant and have been pregnant for more than three months, as the use of this medicine may cause serious harm to the baby if used at this stage of pregnancy (see section “Pregnancy and breast-feeding ”).
Tell your doctor or pharmacist if you:
- take 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
- using diuretic medicines ( diuretics )
- follow a low-salt diet
- have or have had severe vomiting and / or diarrhea
- have heart failure
- have narrowed renal arteries
- has recently undergone kidney transplantation
- have narrowed heart valves ( aortic or mitral stenosis) or a disease leading to myocardial thickening ( hypertrophic cardiomyopathy )
- have diabetes
- has a condition that causes joint pain, rash and fever (which is called systemic lupus erythematosus or lupus , abbreviated SLE )
- get photosensitivity reactions (skin is sensitive to sunlight) while using the medicine
- have a high calcium or potassium value or if you follow a low potassium diet
- need anesthesia e.g. at the dentist or before a surgical procedure
- have symptoms such as severe thirst, dry mouth , general weakness, drowsiness, muscle aches or cramps, nausea, vomiting or rapid heartbeat , which could be a sign of excessive effect of hydrochlorothiazide (included in Irbesartan / Hydrochlorothiazide Sandoz)
- 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 pressure in the eye and may occur within a few hours to weeks after taking Irbesartan / Hydrochlorothiazide Sandoz. Untreated, it can lead to permanent visual impairment. If you have previously had a penicillin and sulfonamide allergy, you may be at a higher risk for this. Stop taking Irbesartan / Hydrochlorothiazide Sandoz and see a doctor
- 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 Sandoz
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 Sandoz”.
Other medicines and Irbesartan / Hydrochlorothiazide Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may need to change your dose and/or take other precautions if you take:
- lithium (a medicine used to treat mania or depression )
- an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Irbesartan / Hydrochlorothiazide Sandoz” and “Warnings and precautions”)
- potassium supplements
- potassium-containing substances that replace salt
- potassium-sparing drugs
- second diuretic agents ( diuretics )
- certain laxatives
- drugs for the treatment of gout
- vitamin D supplementation for therapeutic purposes
- drugs to control heart rhythm
- drugs for the treatment of diabetes (tablets or insulin preparations)
- steroid is
- anti- cancer drugs
- painkillers or drugs for the treatment of joint inflammation
- cholestyramine and cholestipol resins for the treatment of high blood cholesterol
- carbamazepine (a medicine used to treat epilepsy )
Irbesartan / Hydrochlorothiazide Sandoz with food, drink and alcohol
Do not use alcohol when taking these tablets, as alcohol and Irbesartan / Hydrochlorothiazide Sandoz may increase each other’s effects. 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.
Large amounts of salt in the diet can counteract the effect of these tablets.
Irbesartan / Hydrochlorothiazide Sandoz can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you think you may be pregnant (or may become pregnant), consult your doctor. Usually, your doctor will advise you to stop taking Irbesartan / Hydrochlorothiazide Sandoz before pregnancy or as soon as you know you are pregnant and to recommend another medicine instead. Irbesartan / Hydrochlorothiazide Sandoz should not be used during pregnancy and its use is prohibited if the pregnancy lasts for more than 3 months, as the medicine may cause serious harm to the baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breastfeeding or planning to start breastfeeding. Irbesartan / Hydrochlorothiazide Sandoz is not recommended for breastfeeding and your doctor may choose another treatment if you want to breastfeed your baby, especially if your baby is newborn or born prematurely.
Driving and using machines
Irbesartan / Hydrochlorothiazide Sandoz 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 Sandoz contains lactose
Lactose is included in this medicine. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Irbesartan / Hydrochlorothiazide Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free.
How to take Irbesartan / Hydrochlorothiazide Sandoz
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Irbesartan / Hydrochlorothiazide Sandoz is prescribed by your doctor if previous treatment for high blood pressure has not lowered your blood pressure sufficiently.
Your doctor will tell you how to switch from the previous treatment to the new one.
Irbesartan / Hydrochlorothiazide Sandoz 150 mg / 12.5 mg film-coated tablets:
Use for adults and the elderly
The usual dose is one tablet once a day.
Irbesartan / Hydrochlorothiazide Sandoz 300 mg / 25 mg film-coated tablets:
Use for adults and the elderly
The usual dose is one tablet once a day.
Use for children and adolescents (under 18 years)
Irbesartan / Hydrochlorothiazide Sandoz is not recommended for use in children and adolescents below 18 years.
Take the tablet with a glass of water, preferably at the same time each day, with or without food.
If you take more Irbesartan / Hydrochlorothiazide Sandoz than you should
If you take too many tablets, contact the emergency department at the nearest hospital or your doctor immediately. If an overdose occurs, you may experience symptoms due to low blood pressure, e.g. dizziness or a feeling of fainting that can be relieved if you lie down and lift your legs.
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 Sandoz
It is important that you take this medicine every day. But if you miss one or more dose you, you should take dose one as soon as you remember and then continue to use the drug according to the normal schedule. Do not take a double dose to make up for a forgotten dose .
If you stop taking Irbesartan / Hydrochlorothiazide Sandoz
Always consult your doctor if you would like to stop using this medicine. Even if you feel better, you may need to continue using this medicine.
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.
If you notice any of the following side effects, talk to your doctor immediately:
- swelling of the face, lips, mouth, tongue, eyes or throat ( angioedema )
- difficulty breathing, dizziness (severe hypersensitivity).
These symptoms indicate a severe allergic reaction that must be treated immediately , usually in a hospital.
Contact your doctor immediately also in the following cases:
- jaundice (yellow skin color and / or yellowing of the whites of the eyes).
Other side effects are
Common (may affect up to 1 in 10 people):
- dizziness
- nausea / vomiting
- frequent urination needs
- faintness
- increase in blood levels of residual nitrogen, creatinine and creatine kinase.
Uncommon (may affect up to 1 in 100 people):
- diarrhea
- dizziness when getting up
- fainting and low blood pressure
- fast pulse
- swelling ( edema )
- redness
- sexual problems, altered libido
- low potassium and sodium levels in the blood.
Has been reported (occurs in an unknown number of users):
- skin rash, hives , itching
- high potassium levels in the blood
- headache
- ringing, buzzing, noise or clicking in the ears
- cough
- indigestion
- loss of appetite
- altered liver function values or hepatitis
- joint and muscle pain
- renal impairment.
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 decreased platelet count (a blood cell needed for the blood to coagulate) have also been reported.
Side effects are associated with hydrochlorothiazide alone
Decreased appetite, stomach irritation, stomach cramps, constipation, jaundice (yellowish skin and / or yellowish whites of the eyes), inflammation of the pancreas characterized by severe pain in the upper abdomen, often with nausea and vomiting; sleep disorders, depression, blurred vision, lack of white blood cells that can lead to frequent infections , fever, decreased platelet count (a type of blood cell that is important for blood coagulation), decreased number of red blood cells ( anemia ) characterized by fatigue, headache, shortness of breath on exertion, dizziness and pallor; kidney disease, pneumonia including pneumoniaor accumulation of fluid in the lungs; increased skin sensitivity to the sun, inflammation of the blood vessels, a skin disease characterized by skin peeling all over the body, cutaneous lupus erythematosus characterized by a rash that may occur on the face, neck and scalp; allergic reactions, weakness and muscle spasms, changes in heart rate, drop in blood pressure when you get up, swelling of the salivary glands, high blood sugar levels, sugar in the urine, increase in certain blood fats, large amounts of uric acid in the blood that can cause gout; myopia, 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), 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 Sandoz
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 bottle after EXP and on the blister after EXP. The expiration date is the last day of the specified month.
PVC / PVDC / ALU blister:
Do not store above 30 ° C.
Store in the original package. Moisture sensitive.
HDPE bottles and ALU / ALU blisters:
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 .
Irbesartan / Hydrochlorothiazide Sandoz 150 mg / 12.5 mg film-coated tablets:
Each film-coated tablet contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide .
Irbesartan / Hydrochlorothiazide Sandoz 300 mg / 25 mg film-coated tablets:
Each film-coated tablet contains 300 mg irbesartan and 25 mg hydrochlorothiazide .
- Other ingredients are:Tablet core:Microcrystalline cellulose,Lactose monohydrate (see end of section 2 for more information),Croscarmellose sodium,Colloidal anhydrous silica,Hypromellos 3 mPas, Microcrystalline cellulose with silica andMagnesium stearate.
- Tablet coating:Hypromellos 6 mPas,Hydroxypropylcellulose,Macrogol 6000,Lactose monohydrate (see end of section 2 for more information),Titanium dioxide (E171),Iron oxide (150 mg / 12.5 mg: yellow and red; 300 mg / 25 mg: black and red) (E172) andTalc.
What the medicine looks like and contents of the pack
Irbesartan / Hydrochlorothiazide Sandoz 150 mg / 12.5 mg film-coated tablets:
Irbesartan / Hydrochlorothiazide Sandoz is an apricot-colored, oval, biconvex, film-coated tablet marked 150H on one side.
Irbesartan / Hydrochlorothiazide Sandoz 300 mg / 25 mg film-coated tablets:
Irbesartan / Hydrochlorothiazide Sandoz is a dark pink, oval, biconvex, film-coated tablet marked 300 on one side and 25H on the other.
The film-coated tablets are packaged in either PVC / PDVC / ALU blisters or ALU / ALU blisters and placed in a carton or packaged in an HDPE bottle with PP screw cap and silica desiccant.
PVC / PVDC / ALU blisters: 7, 14, 28, 30, 56, 84, 90, 98, 100 film-coated tablets
ALU / ALU blisters: 7, 14, 28, 30, 56, 84, 90, 98, 100 film-coated tablets
HDPE bottle: 100, 250 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Sandoz A / S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark
Manufacturer
Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia
or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, D-39179 Barleben, Germany
or
LEK Pharmaceuticals dd, Trimlini 2D, 9220 Lendava, Slovenia
or
LEK SA, ul. Podlipie 16, 95-010 Stryków, Poland
or
LEK SA, ul. Domaniewska 50 C, 02-672 Warsaw, Poland