Co-bespres

Patient Information Leaflet

Co-Bespres, 160 mg + 12.5 mg, film-coated tablets
Valsartanum + Hydrochlorothiazidum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are similar to yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of Contents

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

1. What Co-Bespres is and what it is used for

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

• Valsartan belongs to a group of medicines known as “angiotensin II receptor antagonists”, which help control high blood pressure. Angiotensin II is a substance produced in the human body that causes blood vessels to constrict, thereby increasing blood pressure. Valsartan works by blocking the action of angiotensin II, resulting in relaxation and widening of blood vessels and a reduction in blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as “water tablets”). Hydrochlorothiazide increases urine output, which also helps lower blood pressure.

Co-Bespres is used to treat high blood pressure that cannot be adequately controlled with only one active substance.
High blood pressure increases the workload on the heart and blood vessels. If left untreated, it may damage blood vessels in the brain, heart, and kidneys, potentially leading to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of such complications.

2. Important information before using Co-Bespres

When not to use Co-Bespres

• if the patient is allergic to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances with a chemical structure similar to hydrochlorothiazide), or to any of the other ingredients of this medicine (listed in section 6).
• if the patient is in pregnancy beyond the 3rd month (it is also better to avoid using the medicine

Co-Bespres during early pregnancy – see section “Pregnancy and breastfeeding”).

• if the patient has severe liver disease, damage to the small bile ducts in the liver (primary biliary cirrhosis) leading to bile accumulation in the liver (cholestasis).
• if the patient has severe kidney disease.
• if the patient is unable to produce urine (anuria).
• if the patient is undergoing dialysis with an artificial kidney.
• if the patient has low blood potassium or sodium levels, or high blood calcium levels, despite treatment.
• if the patient has gout.
• if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above conditions apply to the patient, Co-Bespres must not be used
and the patient should contact a doctor.
Warnings and precautions
Before starting Co-Bespres, discuss this with your doctor or pharmacist.

• if the patient is taking potassium-sparing medicines, potassium supplements, or salt substitutes containing potassium, or other medicines that increase blood potassium levels, such as heparin. It may be necessary for the doctor to monitor blood potassium levels.
• if the patient has low blood potassium levels.
• if the patient has diarrhoea or severe vomiting.
• if the patient is taking high doses of diuretics.
• if the patient has severe heart disease.
• if the patient has heart failure or has had a heart attack. The patient should strictly follow the doctor’s recommendations regarding starting treatment – kidney function monitoring may also be necessary.
• if the patient has renal artery stenosis.
• if the patient has recently received a kidney transplant.
• if the patient has hyperaldosteronism – a condition in which the adrenal glands produce too much of a hormone called aldosterone. In such a case, Co-Bespres is not recommended.
• if the patient has liver or kidney disease.
• if the patient has ever experienced swelling of the tongue and face due to an allergic reaction called angioedema after taking another medicine (including ACE inhibitors), the doctor should be informed. If such symptoms occur while taking Co-Bespres, the medicine must be stopped immediately and must never be used again. See also section 4. “Possible side effects”.
• if the patient has fever, rash, and joint pain, which may be symptoms of systemic lupus erythematosus (SLE, an autoimmune disease).
• if the patient has diabetes, has had gout, or has high cholesterol or triglyceride levels in the blood.
• if the patient has previously experienced allergic reactions after taking other antihypertensive medicines belonging to this group (angiotensin II receptor antagonists), or if the patient has allergies or asthma.
• if the patient experiences blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between choroid and sclera) or increased intraocular pressure, which may occur within hours to weeks after starting Co-Bespres. If untreated, these may lead to complete vision loss. Patients with penicillin or sulphonamide allergy have a higher risk of developing such disorders.
• if the patient is taking any of the following medicines for high blood pressure: ACE inhibitors (e.g., enalapril, lisinopril, ramipril), especially if the patient has kidney function disorders related to diabetes.

or aliskiren.

• if the patient has previously had skin cancer or develops unexpected skin changes during treatment. Treatment with hydrochlorothiazide, especially in high doses over a long period, may increase the risk of certain types of skin and lip cancers (non-melanoma skin cancer). While taking Co-Bespres, the skin should be protected from sunlight and UV radiation.
• if the patient has previously had breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient develops severe shortness of breath or breathing difficulties after taking Co-Bespres, immediate medical help should be sought.

The treating doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g.,
potassium) at regular intervals.
See also information under the heading “When not to use Co-Bespres”.
Co-Bespres may increase skin sensitivity to sunlight.
Inform the doctor if the patient is pregnant, suspects (or is planning) pregnancy.
Co-Bespres is not recommended during early pregnancy and must not be used after the 3rd
month of pregnancy, as it may seriously harm the unborn child (see section
“Pregnancy and breastfeeding”).
If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Co-Bespres,
this should be discussed with the doctor. The doctor will decide on further treatment. Do not
independently decide to stop taking Co-Bespres.
Children and adolescents
Co-Bespres is not recommended for use in children and adolescents (under 18 years of age).
Co-Bespres with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Taking Co-Bespres with certain other medicines may affect treatment. A dose adjustment, additional precautions, or in some cases discontinuation of one of the medicines may be necessary. This particularly applies to the following medicines:

• lithium, a medicine used to treat certain psychiatric disorders
• medicines or substances that may increase blood potassium levels, such as potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin
• medicines that may decrease blood potassium levels, such as diuretics, corticosteroids, laxatives, ACTH (a hormone), carbenoxolone, amphotericin, penicillin G, salicylic acid and its derivatives
• certain antibiotics (rifamycin group), medicines used to prevent rejection of transplanted organs (cyclosporine), or antiretroviral medicines used to treat HIV/AIDS (ritonavir). These medicines may enhance the effect of Co-Bespres.
• medicines that may cause " torsade de pointes " (a heart rhythm disorder), e.g., antiarrhythmics (medicines used to treat heart diseases) and certain antipsychotics
• medicines that may decrease blood sodium levels, such as antidepressants, antipsychotics, antiepileptics
• medicines used to treat gout, such as allopurinol, probenecid, sulfinpyrazone
• vitamin D in therapeutic doses and calcium supplements
• medicines used to treat diabetes (oral medicines such as metformin or insulin)
• other antihypertensive medicines, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also information under the headings “When not to use Co-Bespres” and “Warnings and precautions”)
• medicines that may increase blood pressure, such as noradrenaline or adrenaline
• digoxin or other cardiac glycosides (medicines used to treat heart diseases)
• medicines that may increase blood glucose levels, such as diazoxide or beta-blockers
• cytotoxic medicines (used in cancer treatment) such as methotrexate or cyclophosphamide
• painkillers such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors) and acetylsalicylic acid at doses > 3 g
• muscle relaxants such as tubocurarine
• anticholinergic medicines (used to treat various disorders such as gastrointestinal spasms, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an adjunct in anaesthesia), such as atropine or biperiden
• amantadine (a medicine used to treat Parkinson’s disease and also used to treat or prevent certain viral diseases)
• cholestyramine and colestipol (medicines mainly used to treat high blood lipid levels)
• cyclosporine, a medicine used to prevent rejection of transplanted organs
• alcohol, sedatives, and anaesthetics (medicines with sedative or pain-relieving effects, used, for example, during surgery)
• iodine-containing contrast agents (substances used in imaging procedures).

Co-Bespres with food, drink, and alcohol
Co-Bespres may be taken with or without food.
Alcohol consumption should be avoided until the patient consults a doctor. Alcohol may
further lower blood pressure and (or) increase the risk of dizziness or fainting.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have
a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy

• If the patient is pregnant, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine. The doctor will usually advise discontinuing Co-Bespres before planned pregnancy or immediately after confirmed pregnancy and will recommend another medicine instead of Co-Bespres. Co-Bespres is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child.

Breastfeeding

• If the patient is breastfeeding or intends to start breastfeeding, she should consult a doctor before using this medicine. Co-Bespres is not recommended during breastfeeding. The doctor may recommend another medicine, especially if breastfeeding a newborn or premature infant.

Driving and operating machinery
Before driving, using tools, operating machinery, or performing other tasks requiring concentration, the patient should become familiar with their individual response to Co-Bespres. Like many other medicines used to treat high blood pressure, Co-Bespres may rarely cause dizziness and affect the ability to concentrate.
Co-Bespres contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Co-Bespres

This medicine should always be used exactly as prescribed by your doctor. Following these instructions will help achieve the best results and reduce the risk of adverse effects. If in doubt, consult your doctor or pharmacist.

People with high blood pressure often do not notice any related symptoms and may feel quite well. Therefore, it is all the more important to attend regular check-ups with your doctor, even if you feel well.

Your doctor will inform you how many Co-Bespres tablets you should take. Depending on your response to treatment, your doctor may adjust your dose upwards or downwards.

• The usual recommended dose of Co-Bespres is one tablet daily.
• Do not change the dose or stop treatment without consulting your doctor.
• The medicine should be taken every day at the same time, usually in the morning.
• Co-Bespres can be taken during or independently of meals.
• Swallow the tablet with a glass of water.

Taking more Co-Bespres than prescribed
If you experience severe dizziness and/or fainting, lie down immediately and contact your doctor without delay. In case of accidental overdose, contact your doctor, pharmacist, or go to the emergency department of your nearest hospital.

Missed dose of Co-Bespres
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for the missed one.

Stopping Co-Bespres treatment
Stopping treatment with Co-Bespres may cause your high blood pressure to worsen. Do not discontinue the medicine unless instructed by your doctor.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious and require immediate medical attention:

• Seek immediate medical advice if symptoms of angioedema occur, such as:
• swelling of the face, tongue or throat
• difficulty swallowing
• urticaria and breathing difficulties
• worsening of vision or eye pain due to high intraocular pressure (possible symptoms of fluid accumulation in the avascular membrane surrounding the eye (excessive fluid accumulation between choroid and sclera) or acute angle-closure glaucoma)

The frequency of these adverse reactions is "unknown" (frequency cannot be determined from available data).

• acute respiratory failure (symptoms include: severe shortness of breath, fever, weakness and confusion)
• severe skin disease causing rash, redness of the skin, blistering of the lips, eyelids or inside the mouth, skin peeling, fever (toxic epidermal necrolysis)
• fever, sore throat, increased frequency of infections (agranulocytosis)

These adverse reactions occur very rarely (may affect fewer than 1 in 10,000 patients).
If any of these symptoms occur, treatment with Co-Bespres must be discontinued and medical advice sought immediately
(see also section 2. "Warnings and precautions")
Other adverse reactions include:
Not common (may affect fewer than 1 in 100 patients)

• cough
• low blood pressure
• sensation of "emptiness" in the head
• dehydration (with feeling of thirst, dryness of the oral mucosa and tongue, infrequent urination, dark urine color, dry skin)
• muscle pain
• feeling of fatigue
• tingling or numbness
• blurred vision
• tinnitus (e.g. ringing, buzzing)

Very rare (may affect fewer than 1 in 10,000 patients)

• dizziness
• diarrhea
• joint pain

Frequency unknown (frequency cannot be determined from available data)

• breathing difficulties
• significantly reduced urine output
• low blood sodium levels (which may cause fatigue, confusion, muscle twitching and/or seizures in severe cases)
• low blood potassium levels (sometimes with muscle weakness, muscle cramps, cardiac arrhythmias)
• low white blood cell count (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infection, weakness)
• increased blood bilirubin levels (which may, in severe cases, cause yellowing of the skin and eyes)
• increased blood urea and creatinine levels (which may indicate impaired kidney function)
• increased blood uric acid levels (which may, in severe cases, trigger gout)
• fainting

The following adverse reactions have been reported after administration of walsartan alone or hydrochlorothiazide alone:
Walsartan
Not common (may affect fewer than 1 in 100 patients)

• sensation of spinning
• abdominal pain

Very rare (may affect fewer than 1 in 10,000 patients)

• intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhea

Frequency unknown (frequency cannot be determined from available data)

• blister formation (symptom of bullous dermatitis)
• skin rash with or without itching, occurring with one or more of the following objective or subjective symptoms: fever, joint pain, muscle pain, lymph node swelling and/or flu-like symptoms
• rash, purple-red spots, fever, itching (symptoms of vasculitis)
• low platelet count (sometimes with unexplained bleeding or bruising)
• high blood potassium levels (sometimes with muscle cramps, cardiac arrhythmias)
• allergic reactions (with symptoms such as rash, itching, urticaria, breathing difficulties or swallowing difficulties, dizziness)
• swelling, mainly of the face and throat; rash; itching
• increased liver enzyme activity
• decreased hemoglobin concentration and hematocrit values (both parameters may indicate anemia in severe cases)
• renal failure
• low blood sodium levels (which may cause fatigue, confusion, muscle twitching and/or seizures in severe cases)

Hydrochlorothiazide
Very common (may affect more than 1 in 10 patients)

• low blood potassium levels
• increased blood lipid levels

Common (may affect fewer than 1 in 10 patients)

• low blood sodium levels
• low blood magnesium levels
• high blood uric acid levels
• itchy rash and other types of skin rash
• loss of appetite
• mild nausea and vomiting
• dizziness, fainting upon standing
• inability to achieve or maintain erection

Uncommon (may affect fewer than 1 in 1,000 patients)

• swelling and blistering of the skin (due to increased sensitivity to sunlight)
• high blood calcium levels
• high blood glucose levels
• presence of glucose in urine
• worsening of metabolic status in diabetes
• constipation, diarrhea, discomfort in the stomach or intestines, liver disorders which may occur together with yellowing of the skin or eyes
• cardiac arrhythmias
• headache
• sleep disturbances
• low mood (depression)
• low platelet count (sometimes with bleeding or subcutaneous bruising)
• dizziness
• tingling or numbness
• visual disturbances

Very rare (may affect fewer than 1 in 10,000 patients)

• vasculitis with symptoms such as rash, purple-red spots, fever
• rash, itching, urticaria, breathing or swallowing difficulties, dizziness (hypersensitivity reactions)
• facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
• severe upper abdominal pain (pancreatitis)
• breathing difficulties with fever, cough, wheezing, shortness of breath (respiratory failure including pneumonia and pulmonary edema)
• pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia)
• fever, sore throat or mouth ulcers due to infections (leukopenia)
• confusion, fatigue, tremor and muscle cramps, rapid breathing (hypochloremic alkalosis)
• absence or low number of various blood cells

Frequency unknown (frequency cannot be determined from available data)

• weakness, bruising and frequent infections (aplastic anemia)
• significantly reduced urine output (possible symptoms of kidney function disorders or renal failure)
• rash, redness of the skin, blistering of the lips, eyelids or inside the mouth, skin peeling, fever (possible symptoms of erythema multiforme)
• muscle cramps
• fever
• weakness (asthenia)
• skin and lip malignancies (non-melanoma skin cancers)

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Co-Bespres

• Keep the medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton or blister after "Expiry date/EXP". The expiry date refers to the last day of the specified month.
• Do not store above 30°C.
• Do not use Co-Bespres if the packaging is damaged or shows any signs of tampering.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the package and other information

What Co-Bespres contains

• The active substances are: valsartan and hydrochlorothiazide. Each film-coated tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.
• Other ingredients are: colloidal anhydrous silica, sodium carboxymethyl starch (Type A), crospovidone, microcrystalline cellulose, maize starch, magnesium stearate, and Opadry 03F25380 red (hypromellose, polyethylene glycol 8000, talc, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172)).

What Co-Bespres looks like and contents of the pack

• Co-Bespres 160 mg + 12.5 mg film-coated tablets are red, convex, round film-coated tablets with the imprint "VH" on one side.
• The medicine is available in packs containing 14, 28, 30, 56 and 60 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel.: (22) 345 93 00

Manufacturer
Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Teva Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
Teva Czech Industries s.r.o., Ostravská 29, c.p. 305, 747 70 Opava-Komárov, Czech Republic
Teva Pharma, S.L.U., C/ C, n° 4, Poligono Industrial Malpica, 50016 Zaragoza, Spain
Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków