COTAREG 50 mg/850 mg Фильм-Coated Таблетки

Содержание инструкции

1. Cotareg 80 mg/12,5 mg film-coated tablets, 160 mg/12,5 mg film-coated tablets, 160 mg/25 mg film-coated tablets, 320 mg/12,5 mg film-coated tablets, 320 mg/25 mg film-coated tablets
   1. What Cotareg is and what it is used for
   2. What you need to know before taking Cotareg
   3. How to take Cotareg
   4. Possible side effects
   5. How to store Cotareg
   6. Package contents and other information

Cotareg 80 mg/12,5 mg film-coated tablets, 160 mg/12,5 mg film-coated tablets, 160 mg/25 mg film-coated tablets, 320 mg/12,5 mg film-coated tablets, 320 mg/25 mg film-coated tablets

Valsartan/hydrochlorothiazide

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Cotareg is and what it is used for
• 2. What you need to know before you take Cotareg
• 3. How to take Cotareg
• 4. Possible side effects
• 5. How to store Cotareg
• 6. Contents of the pack and other information

1. What Cotareg is and what it is used for

Cotareg film-coated tablets contain two active ingredients called valsartan and
hydrochlorothiazide. Both of these substances help to control high blood pressure (hypertension).

• Valsartanbelongs to a class of medicines known as “angiotensin II receptor antagonists”, which help to control high blood pressure. Angiotensin II is a substance in the body that causes the narrowing of blood vessels, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II. The result is that blood vessels relax and blood pressure decreases.
• Hydrochlorothiazidebelongs to a group of medicines called thiazide diuretics. Hydrochlorothiazide increases the amount of urine eliminated and, in doing so, reduces blood pressure.

Cotareg is used in the treatment of high blood pressure when blood pressure is not sufficiently
controlled by a single medicine.
When blood pressure is high, the workload on the heart and arteries increases. If not
treated, it can damage the blood vessels of the brain, heart and kidneys and can lead to stroke, heart
failure or kidney failure. High blood pressure increases the risk of heart attack. Bringing blood
pressure back to normal values reduces the risk of developing these conditions.

2. What you need to know before taking Cotareg

Do not take Cotareg:

• if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related substances to hydrochlorothiazide) or any of the excipients of this medicine (listed in section 6)
• if you are pregnant for more than 3 months(it is best to avoid taking Cotareg even in the early stages of pregnancy - see the Pregnancy section)
• if you have severeliver disorders, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to bile accumulation in the liver (cholestasis)
• if you have severekidney disorders
• if you are unable to urinate (anuria)
• if you are undergoing treatment with an artificial kidney
• if your potassium or sodium levels in the blood are lower than normal or if your calcium levels in the blood are higher than normal despite treatment
• if you have gout
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure containing aliskiren.

If any of the above applies to you, do not take this medicine and consult your
doctor.
Warnings and precautions
Consult your doctor

• if you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium or other medicines that increase potassium levels in the blood, such as heparin. Your doctor may need to check your potassium level in the blood at regular intervals
• if your potassium levels in the blood are low
• if you have diarrhea or severe vomiting
• if you are taking high doses of medicines that increase fluid elimination (diuretics)
• if you have serious heart problems
• if you suffer from heart failure or have had a heart attack. Carefully follow your doctor's instructions regarding the starting dose of therapy. Your doctor will also check your kidney function
• if you suffer from a narrowing of the renal artery
• if you have recently received a new kidney
• if you suffer from hyperaldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. If this applies to you, the use of Cotareg is not recommended
• if you have liver or kidney disease
• if you have previously experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medicines (including ACE inhibitors), inform your doctor. If these symptoms occur while taking Cotareg, stop taking Cotareg immediately and never take it again. See section 4, “Possible side effects”
• if you have fever, rash and joint pain, which may be a sign of systemic lupus erythematosus (SLE, an autoimmune disease)
• if you have diabetes, gout, high levels of cholesterol or triglycerides in the blood
• if you have had allergic reactions with the use of other medicines that lower blood pressure belonging to the same class (angiotensin II receptor antagonists) or if you suffer from allergies or asthma
• if you experience decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and can occur from a few hours to weeks after taking Cotareg. If left untreated, this can lead to permanent vision loss. If you have previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this disorder.
• if you are taking any of the following medicines used to treat high blood pressure:
• an “ACE inhibitor” (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• aliskiren
• if you have had skin cancer in the past or if you are developing an unexpected skin lesion

during treatment. Treatment with hydrochlorothiazide, especially long-term
use with high doses, can increase the risk of certain types of skin cancer and lip cancer
(non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays
while taking Cotareg.

• if you have had breathing or lung problems (including inflammation or fluid in the lungs) following the use of hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Cotareg, consult a doctor immediately.

Your doctor may check your kidney function, blood pressure and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.
See also what is stated under “Do not take Cotareg”.
Cotareg may cause increased sensitivity of the skin to the sun.
The use of Cotareg is not recommended in children and adolescents (under 18 years of age).
You should inform your doctor if you think you may be pregnant (or if there is a possibility of
becoming pregnant). Cotareg is not recommended in early pregnancy and should not be taken if
you are pregnant for more than 3 months, as it can cause serious harm to the baby if taken in
this period (see the Pregnancy section).

Taking other medicines and Cotareg
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The effect of the treatment may be affected if Cotareg is taken with certain other medicines. It may
be necessary to change the dose, take other precautions or, in some cases, stop taking one of the
medicines. This applies particularly to the following medicines:

• lithium, a medicine used to treat some mental disorders
• medicines or substances that can increase the amount of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin
• medicines that can decrease the amount of potassium in the blood, such as diuretics (medicines that increase fluid elimination), corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G
• some antibiotics (rifampicin group), a medicine used against rejection in transplantation (cyclosporine) and an antiretroviral medicine used to treat HIV/AIDS infections (ritonavir). These medicines can increase the effect of Cotareg
• medicines that can induce torsades de pointes (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics
• medicines that can reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics
• medicines for the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone
• therapeutic vitamin D and calcium supplements
• medicines used to treat diabetes (oral use such as metformin or insulins)
• other medicines that lower blood pressure, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also “Do not take Cotareg” and “Warnings and precautions”)
• medicines that increase blood pressure, such as norepinephrine or epinephrine
• digoxin or other cardiac glycosides (medicines used to treat heart problems)
• medicines that can increase blood sugar levels, such as diazoxide or beta-blockers
• cytotoxic medicines (used for cancer treatment), such as methotrexate or cyclophosphamide
• pain relievers such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (Cox-2) inhibitors and acetylsalicylic acid > 3 g
• muscle relaxants, such as tubocurarine
• anti-cholinergic medicines (medicines used to treat various disorders such as gastrointestinal cramps, bladder spasm, asthma, motion sickness, muscle spasms, Parkinson's disease and to facilitate anesthesia)
• amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent some viral infections)
• cholestyramine and colestipol (medicines used mainly to treat high levels of lipids in the blood)
• cyclosporine, a medicine used in organ transplantation to prevent organ rejection
• alcohol, sleeping pills and anesthetics (medicines with a narcotic or analgesic effect used, for example, during surgery)
• iodinated contrast agents (used for radiological examinations)

Taking Cotareg with food and drink
Avoid drinking alcohol unless you have discussed it with your doctor. Alcohol can
further reduce blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

• You should inform your doctor if you think you may be pregnant (or if there is a possibility ofbecoming pregnant)Generally, your doctor will advise you to stop taking Cotareg before becoming pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of Cotareg. Cotareg is not recommended in early pregnancy and should not be taken if you are pregnant for more than 3 months as it can cause serious harm to the baby if taken after the third month of pregnancy.
• Tell your doctor if you are breastfeeding, or are planning to start breastfeedingCotareg is not recommended for women who are breastfeeding and your doctor may choose another treatment for you if you wish to breastfeed, especially if the baby is newborn or premature.

Driving and operating machinery
Before driving a vehicle, using machinery or performing other activities that require
concentration, it is good to know your reaction to Cotareg. Like many other medicines used to
treat high blood pressure, Cotareg can rarely cause dizziness and affect the ability to
concentrate.
For those who play sports: the use of the drug without therapeutic need constitutes doping and can
still result in positive doping tests.

3. How to take Cotareg

Take this medicine following exactly the instructions of your doctor. This will help you to
obtain the best results and to reduce the risk of side effects. If you have any doubts, consult your doctor or
pharmacist.
Those who suffer from high blood pressure often do not notice any signs of this problem and many feel
as well as usual. For this reason, it is very important that you keep regular
appointments with your doctor, even when you feel well.
The doctor will tell you exactly how many Cotareg tablets you need to take. Based on your response
to treatment, the doctor may suggest a higher or lower dose.

• The recommended dose of Cotareg is one tablet a day.
• Do not change the dose and do not stop taking the tablets without first consulting your doctor.
• This medicine should be taken every day at the same time, usually in the morning.
• You can take Cotareg with or without food.
• Swallow the tablet with a glass of water.

If you take more Cotareg than you should
In case of severe dizziness and/or fainting, it is good to lie down and contact your doctor immediately.
If you have inadvertently taken too many tablets, contact your doctor, pharmacist or hospital.

If you forget to take Cotareg
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the
next tablet, skip the forgotten dose.
Do not take a double dose to make up for a missed dose.

If you stop taking Cotareg
Stopping treatment with Cotareg may cause high blood pressure to worsen. Do not
discontinue use of the medicine unless you have been told to do so by your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects may be serious and require immediate medical attention

• Consult your doctor immediately if you have symptoms of angioedema, such as:
• swelling of the face, tongue or throat
• difficulty swallowing
• urticaria and difficulty breathing
• Severe skin diseases causing rash, redness of the skin, formation of blisters on lips, eyes or mouth, peeling of the skin, fever (toxic epidermal necrolysis)
• Decreased vision or eye pain due to high eye pressure (possible sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• Fever, sore throat, more frequent infections (agranulocytosis)
• severe shortness of breath, fever, weakness and confusion (acute respiratory distress).

These side effects are very rare or of unknown frequency.

If you experience any of these symptoms, stop taking Cotareg and contact your doctor immediately
(see also section 2 “Warnings and precautions”).
Other side effects are:

Not common (may affect up to 1 in 100 people)

• cough
• low blood pressure
• feeling of emptiness in the head
• dehydration (with symptoms such as thirst, dry mouth and tongue, infrequent urination, dark urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• ringing in the ears (e.g. buzzing, whistling)

Very rare (may affect up to 1 in 10,000 people)

• dizziness
• diarrhoea
• joint pain

Not known (frequency cannot be estimated from available data)

• difficulty breathing
• significant decrease in the amount of urine
• low sodium levels in the blood (which can cause fatigue, mental confusion, muscle contractions and/or convulsions in severe cases)
• low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)
• low levels of white blood cells in the blood (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
• increased levels of bilirubin in the blood (which can, in severe cases, cause yellowing of the skin and eyes)
• increased levels of urea and creatinine in the blood (which may be an indication of kidney dysfunction)
• increased levels of uric acid in the blood (which can, in severe cases, cause gout)
• syncope (fainting)

The following side effects have been reported with medicines containing valsartan or
hydrochlorothiazide alone
Valsartan

Not common (may affect up to 1 in 100people)

• feeling of dizziness
• abdominal pain

Not known (frequency cannot be estimated from available data)

• appearance of blisters on the skin (sign of bullous dermatitis)
• rash with or without itching along with some of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
• rash, reddish-purple spots, fever, itching (symptoms of blood vessel inflammation)
• low platelet levels in the blood (sometimes with unusual bleeding or bruising)
• increased potassium levels in the blood (sometimes with muscle spasms, abnormal heart rhythm)
• allergic reactions (with symptoms such as rash, itching, urticaria, difficulty breathing or swallowing, dizziness)
• swelling especially of the face and throat, rash, itching
• increased liver function values
• decreased levels of hemoglobin and percentage of red blood cells in the blood (which, in severe cases, can both cause anemia)
• kidney failure
• low sodium levels in the blood (which can cause fatigue, mental confusion, muscle contractions and/or convulsions in severe cases)

Hydrochlorothiazide

Very common (may affect more than 1 in 10 people)

• low potassium levels in the blood
• increased lipids in the blood

Common (may affect up to 1 in 10 people)

• low sodium levels in the blood
• low magnesium levels in the blood
• high uric acid levels in the blood
• rashes with itching or other types of rash
• loss of appetite
• mild nausea and vomiting
• dizziness, fainting when getting up
• inability to achieve or maintain an erection

Rare (may affect up to 1 in 1,000)

• swelling and blistering of the skin (due to increased sensitivity to the sun)
• high calcium levels in the blood
• high sugar levels in the blood
• sugar in the urine
• worsening of the metabolic state of diabetes
• constipation, diarrhea, stomach or intestinal disorders, liver disorders that can manifest with yellow skin and eyes
• irregular heartbeat
• headache
• sleep disturbances
• sadness (depression)
• low platelet levels in the blood (sometimes with bleeding or bruising under the skin)
• dizziness
• tingling or numbness
• visual disturbances

Very rare (may affect up to 1 in 10,000)

• inflammation of blood vessels with symptoms such as rash, reddish-purple spots, fever (vasculitis)
• rash, itching, urticaria, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• rashes on the face, joint pain, muscle disorders, fever (lupus erythematosus)
• severe pain in the upper abdomen (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, including pneumonia and pulmonary edema)
• paleness, fatigue, shortness of breath, dark urine (hemolytic anemia)
• fever, sore throat or mouth ulcers due to infections (leukopenia)
• confusion, fatigue, tremor and muscle spasm, rapid breathing (hypochloremic alkalosis)

Not known (frequency cannot be estimated from available data)

• fatigue, bruising and frequent infections (aplastic anemia)
• severe decrease in the amount of urine (possible sign of a kidney disorder or kidney failure)
• rash, redness of the skin, formation of blisters on lips, eyes or mouth, peeling of the skin, fever (possible signs of erythema multiforme)
• muscle spasm
• fever (pyrexia)
• weakness (asthenia)
• skin and lip cancer (non-melanoma skin cancer)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or
pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Cotareg

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date that is reported on the pack. The expiry date refers to the last day of the month.
• Do not store at a temperature above 30°C. Store in the original package to protect the medicine from moisture.
• Do not use this medicine if you notice that the package is damaged or shows signs of tampering.
• Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cotareg contains

• The active ingredients are valsartan and hydrochlorothiazide. Each film-coated tablet contains 80 mg, 160 mg or 320 mg of valsartan and 12.5 mg or 25 mg of hydrochlorothiazide, respectively.
• The tablet core contains microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate
• The tablet coating contains hypromellose, macrogol 8000 (only 80 mg/12.5 mg and 160 mg/12.5 mg), macrogol 4000 (only 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg), talc, red iron oxide (E172, except for 320 mg/25 mg), yellow iron oxide (E172, only 80 mg/12.5 mg, 160 mg/12.5 mg and 320 mg/12.5 mg), black iron oxide (E172, only 160 mg/25 mg and 320 mg/12.5 mg), titanium dioxide (E171).

Description of the appearance of Cotareg and contents of the pack
Cotareg 80 mg/12.5 mg film-coated tablets are light orange, ovoid, with “HGH” imprinted
on one side and “CG” on the other side.
Cotareg 160 mg/12.5 mg film-coated tablets are dark red, ovoid, with “HHH” imprinted
on one side and “CG” on the other side.
Cotareg 160 mg/25 mg film-coated tablets are brown, ovoid, with “HXH” imprinted
on one side and “NVR” on the other side.
Cotareg 320 mg/12.5 mg film-coated tablets are pink, ovoid, with beveled edges, with
“NVR” imprinted on one side and “HIL” on the other side.
Cotareg 320 mg/25 mg film-coated tablets are yellow, ovoid, with “CTI” imprinted on
one side and “NVR” on the other side.
The tablets are available in packs with blisters of 7 tablets (only Cotareg 320 mg/12.5 mg and
320 mg/25 mg), 14 tablets, 28 tablets as a calendar pack, 30 tablets (only Cotareg
80 mg/12.5 mg), 56 tablets, 98 tablets as a calendar pack or 280 tablets. Unit-dose divisible blisters are also available in packs of 56x1, 98x1 or 280x1 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Novartis Farma S.p.A.
Largo Umberto Boccioni 1
21040 Origgio VA
Italy

Manufacturer
Novartis Farma S.p.A.
Via Provinciale Schito 131
80058 Torre Annunziata NA
Italy

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following denominations: