Co-bespres

LEAFLET INCLUDED IN THE PACKAGING: PATIENT INFORMATION

Co-Bespres, 80 mg + 12.5 mg, film-coated tablets

Co-Bespres, 160 mg + 25 mg, film-coated tablets

Valsartan + Hydrochlorothiazide

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Co-Bespres and what is it used for
• 2. Important information 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 is Co-Bespres and what is it used for

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

• Valsartanbelongs to a group of medicines called "angiotensin II receptor antagonists", which help to 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 the dilation of blood vessels and a decrease in blood pressure.
• Hydrochlorothiazidebelongs to a group of medicines called thiazide diuretics (also known as "diuretics"). Hydrochlorothiazide increases urine production, which also lowers blood pressure.

Co-Bespres is used to treat high blood pressure that cannot be controlled by taking only one active substance.

High blood pressure increases the strain on the heart and arteries. If left untreated, it can lead to damage to the blood vessels in the brain, heart, and kidneys, which can result in stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of such disorders.

2. Important information before taking Co-Bespres

When not to take Co-Bespres

• if you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (substances with a similar chemical structure to hydrochlorothiazide), or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant over 3 months (it is also recommended to avoid taking Co-Bespres in early pregnancy - see section 2: Pregnancy and breastfeeding).
• if you have severe liver disease, bile duct obstruction (bile duct obstruction leading to bile accumulation in the liver) leading to jaundice.
• if you have severe kidney disease.
• if you are unable to produce urine (anuria).
• if you are undergoing hemodialysis.
• if you have low potassium or sodium levels in your blood, or high calcium levels in your blood, despite treatment.
• if you have gout.
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren.

If any of the above conditions apply to you, do not take Co-Bespres and consult your doctor.

Warnings and precautions

Before starting treatment with Co-Bespres, you should discuss it with your doctor or pharmacist.

• if you are taking potassium-sparing medicines, potassium supplements, or salt substitutes containing potassium, or other medicines that increase potassium levels in your blood, such as heparin. Your doctor may need to monitor your potassium levels in your blood.
• if you have low potassium levels in your blood.
• if you have diarrhea or severe vomiting.
• if you are taking high doses of diuretics (diuretics).
• if you have severe heart disease.
• if you have heart failure or have had a heart attack. You should strictly follow your doctor's recommendations for starting treatment - kidney function monitoring may also be necessary.
• if you have narrowing of the renal artery.
• if you have had a kidney transplant recently.
• if you have hyperaldosteronism - a disease in which the adrenal glands produce too much of a hormone called aldosterone. In this case, it is not recommended to take Co-Bespres.
• if you have liver or kidney disease.
• if you have ever had swelling of the tongue and face caused by an allergic reaction, called angioedema, after taking another medicine (including ACE inhibitors). You should inform your doctor about this. If such symptoms occur while taking Co-Bespres, you should stop taking it immediately and never take it again. See section 4 "Possible side effects".
• if you have fever, rash, and joint pain, which may be symptoms of systemic lupus erythematosus (SLE, an autoimmune disease).
• if you have diabetes, have had gout, have high cholesterol or triglyceride levels in your blood.
• if you have had allergic reactions to other blood pressure-lowering medicines of this group (angiotensin II receptor antagonists) or if you are allergic or have asthma.
• if you have impaired vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased pressure in the eye, which can occur within a few hours to a few weeks after starting Co-Bespres. If left untreated, they can lead to complete loss of vision. In patients allergic to penicillin or sulfonamides, the risk of such disorders is higher.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g. potassium) in your blood at regular intervals.

See also the information under the heading "When not to take Co-Bespres".

Co-Bespres may cause increased sensitivity of the skin to sunlight.

You should tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.

Co-Bespres should not be taken during pregnancy and should not be taken after 3 months of pregnancy, as it may seriously harm the baby (see section "Pregnancy and breastfeeding").

If you experience abdominal pain, nausea, vomiting, or diarrhea after taking Co-Bespres, you should discuss it with your doctor. Your doctor will decide on further treatment. You should not stop taking Co-Bespres on your own.

Children and adolescents

Co-Bespres should not be taken by children and adolescents (under 18 years of age).

Co-Bespres with other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.

Taking Co-Bespres with certain other medicines may affect treatment. A dose change, other precautions, or, in some cases, discontinuation of one of the medicines may be necessary. This applies in particular to the following medicines:

• Lithium, a medicine used to treat certain mental illnesses.
• Medicines or substances that can increase potassium levels in your blood, such as potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin.
• Medicines that can decrease potassium levels in your blood, such as diuretics, corticosteroids, laxatives, ACTH (adrenocorticotropic hormone), carbenoxolone, amphotericin, penicillin G, salicylic acid, and its derivatives.
• Certain antibiotics (from the rifamycin group), medicines used to prevent rejection of a transplanted organ (cyclosporine), or antiretroviral medicines used to treat HIV/AIDS (ritonavir). These medicines may enhance the effect of Co-Bespres.
• Medicines that can cause "torsades de pointes" (heart rhythm disorders), such as anti-arrhythmic medicines (medicines used to treat heart diseases) and certain antipsychotic medicines.
• Medicines that can decrease sodium levels in your blood, 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 blood pressure-lowering medicines, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also the information under the heading "When not to take Co-Bespres" and "Warnings and precautions").
• Medicines that increase blood pressure, such as norepinephrine or epinephrine.
• Digoxin or other digitalis glycosides (medicines used to treat heart diseases).
• Medicines that can increase blood sugar levels, such as diazoxide or beta-adrenergic blockers.
• Cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide.
• Painkillers, such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors and acetylsalicylic acid in a dose > 3 g.
• Muscle relaxants, such as tubocurarine.
• Anticholinergic medicines (medicines used to treat various disorders, such as gastrointestinal spasms, urinary spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an adjunct in anesthesia), 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 used mainly to treat high lipid levels in the blood).
• Cyclosporine, a medicine used in patients with a transplanted organ to prevent rejection.
• Alcohol, sedatives, and anesthetics (medicines with a sedative or analgesic effect, used, for example, during surgery).
• Contrast agents containing iodine (agents used for imaging tests).

Co-Bespres with food, drink, and alcohol

Co-Bespres can be taken with or without food.

You should avoid consuming alcohol until you have consulted your doctor. Alcohol may cause further lowering of blood pressure and (or) increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.

Pregnancy

• If you are pregnant, think you may be pregnant, or are planning to have a baby, you should consult your doctor before taking this medicine.Your doctor will usually recommend stopping Co-Bespres before planned pregnancy or as soon as pregnancy is confirmed, and will recommend taking another medicine instead of Co-Bespres. Co-Bespres should not be taken during early pregnancy and should not be taken after 3 months of pregnancy, as it may seriously harm the baby.

Breastfeeding

• If you are breastfeeding or plan to start breastfeeding, you should consult your doctor before taking this medicine.Co-Bespres is not recommended during breastfeeding. Your doctor may recommend taking another medicine, especially if you are breastfeeding a newborn or premature baby.

Driving and using machines

Before driving, using tools, operating machines, or performing other activities that require concentration, you should know your individual reaction to Co-Bespres.

Like many other medicines used to treat high blood pressure, Co-Bespres may rarely cause dizziness and affect concentration.

Co-Bespres contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially "sodium-free".

Co-Bespres 80 mg + 12.5 mg contains orange yellow S (E110)

Co-Bespres contains orange yellow S (E110), which may cause allergic reactions.

3. How to take Co-Bespres

This medicine should always be taken exactly as directed by your doctor. This will help you get the best results and reduce the risk of side effects.

In case of doubt, you should consult your doctor or pharmacist.

People with high blood pressure often do not notice any symptoms associated with it. Many of them feel quite well. Therefore, it is even more important to attend follow-up appointments with your doctor, even if you feel well.

Your doctor will tell you how many Co-Bespres tablets to take. Depending on your response to treatment, your doctor may recommend a higher or lower dose.

• The recommended dose of Co-Bespres is one tablet per day.
• You should not change the dose or stop treatment without consulting your doctor.
• The medicine should be taken daily at the same time, usually in the morning.
• Co-Bespres can be taken with or without food.
• The tablet should be swallowed with a glass of water.

Taking a higher dose of Co-Bespres than recommended

In case of severe dizziness and (or) fainting, you should lie down and contact your doctor immediately.

In case of accidental overdose, you should contact your doctor, pharmacist, or go to the emergency department of the nearest hospital.

Missing a dose of Co-Bespres

In case of a missed dose, you should take it as soon as you remember. However, if it is almost time for the next dose, you should skip the missed dose.

You should not take a double dose to make up for a missed dose.

Stopping treatment with Co-Bespres

Stopping treatment with Co-Bespres may cause your blood pressure to rise. You should not stop taking Co-Bespres unless your doctor tells you to.

If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Co-Bespres can cause side effects, although not everybody gets them.

Some side effects may be serious and require immediate medical attention:

• you should contact your doctor immediately if you experience symptoms of angioedema, such as:
• swelling of the face, tongue, or throat
• difficulty swallowing
• hives and difficulty breathing
• impaired vision or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute angle-closure glaucoma).

The frequency of these side effects is unknown (cannot be estimated from the available data)

• severe skin diseases causing rash, redness of the skin, blistering of the lips, eyes, or mucous membranes, peeling of the skin, fever (toxic epidermal necrolysis)
• fever, sore throat, frequent infections (agranulocytosis)
• acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).

These side effects are very rare (may affect less than 1 in 10,000 people).

If you experience any of these symptoms, you should stop taking Co-Bespres and contact your doctor immediately (see also section 2 "Warnings and precautions").

Other side effects include:

Uncommon (may affect less than 1 in 100 people)

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

Rare (may affect less than 1 in 1,000 people)

• dizziness
• diarrhea
• joint pain

Frequency not known (frequency cannot be estimated from the available data)

• breathing difficulties
• significant decrease in urine output
• low sodium levels in the blood (which may cause fatigue, confusion, tremors, and (or) seizures in severe cases)
• low potassium levels in the blood (sometimes with muscle weakness, muscle cramps, heart rhythm disorders)
• low white blood cell count (sometimes with symptoms such as fever, skin infections, sore throat, or mouth ulcers caused by infection, weakness)
• increased bilirubin levels in the blood (which may, in severe cases, cause yellowing of the skin and eyes)
• increased urea and creatinine levels in the blood (which may indicate impaired kidney function)
• increased uric acid levels in the blood (which may, in severe cases, cause gout)
• fainting

The following side effects have been reported with valsartan or hydrochlorothiazide alone:

Valsartan

Uncommon (may affect less than 1 in 100 people)

• vertigo
• abdominal pain

Rare (may affect less than 1 in 10,000 people)

• angioedema of the intestine: swelling of the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Frequency not known (frequency cannot be estimated from the available data)

• blistering (symptom of bullous pemphigoid)
• skin rash with itching or without, accompanied by some of the following symptoms: fever, joint pain, muscle pain, swollen lymph nodes, and (or) flu-like symptoms
• rash, purple spots, fever, joint pain (symptoms of vasculitis)
• low platelet count (sometimes with unexplained bleeding or bruising)
• high potassium levels in the blood (sometimes with muscle cramps, heart rhythm disorders)
• allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
• swelling, mainly of the face and throat; rash; itching
• increased liver enzyme activity
• decreased hemoglobin and hematocrit values (both parameters may indicate anemia in severe cases)
• kidney failure
• low sodium levels in the blood (which may cause fatigue, confusion, tremors, and (or) seizures in severe cases)

Hydrochlorothiazide

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

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

Common (may affect less than 1 in 10 people)

• low sodium levels in the blood
• low magnesium levels in the blood
• high uric acid levels in the blood
• itching rash and other types of rash
• loss of appetite
• mild nausea and vomiting
• dizziness, fainting when standing up
• impotence

Rare (may affect less than 1 in 1,000 people)

• swelling and blistering of the skin due to increased sensitivity to sunlight
• high calcium levels in the blood
• high blood sugar levels
• presence of sugar in the urine
• worsening of metabolic disorders in diabetes
• constipation, diarrhea, feeling of discomfort in the stomach or intestines, liver disorders, which may occur with yellowing of the skin and eyes
• heart rhythm disorders
• headache
• sleep disorders
• depression
• low platelet count (sometimes with bleeding or bruising)
• dizziness
• tingling or numbness
• vision disorders

Very rare (may affect less than 1 in 10,000 people)

• vasculitis with symptoms such as rash, purple spots, fever
• rash, itching, hives, difficulty breathing or swallowing, dizziness (allergic reactions)
• rash, joint pain, muscle pain, fever (symptoms of lupus erythematosus)
• severe 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 caused by infection (leukopenia)
• confusion, fatigue, tremors, and muscle cramps (hypochloremic alkalosis)
• low blood cell count

Frequency not known (frequency cannot be estimated from the available data)

• weakness, bruising, and frequent infections (aplastic anemia)
• significant decrease in urine output (possible symptoms of kidney disorders or kidney failure)
• rash, redness of the skin, blistering of the lips, eyes, or mucous membranes, peeling of the skin, fever (possible symptoms of erythema multiforme)
• muscle cramps
• fever
• weakness (asthenia)
• skin cancer and lip cancer (non-melanoma skin cancer).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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

By reporting side effects, you can help provide more information on the safety of this medicine.

Side effects can also be reported to the marketing authorization holder.

5. How to store Co-Bespres

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

6. Contents of the pack and other information

What Co-Bespres contains

The active substances of Co-Bespres are valsartan and hydrochlorothiazide. Each tablet contains 80 mg/160 mg of valsartan and 12.5 mg/25 mg of hydrochlorothiazide.

Other ingredients of the medicine are: colloidal anhydrous silica, sodium carboxymethylcellulose (type A), crospovidone, microcrystalline cellulose, maize starch, magnesium stearate.

The tablet coating contains:

80 mg + 12.5 mg: hypromellose, macrogol 8000, talc, titanium dioxide (E171), orange yellow S (E110), iron oxide red (E172).

160 mg + 25 mg: hypromellose, macrogol 8000, talc, titanium dioxide (E171), iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172).

What Co-Bespres looks like and contents of the pack

Co-Bespres, 80 mg + 12.5 mg, film-coated tablets

Round, pink film-coated tablets, with the number "93" embossed on one side of the tablet and "7428" on the other side.

Co-Bespres, 160 mg + 25 mg, film-coated tablets

Round, brown film-coated tablets, with the number "93" embossed on one side of the tablet and "7430" on the other side.

The product is available in packs of 14, 28, 30, 56, and 60 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Warsaw

tel.: (22) 345 93 00

Manufacturer

Teva Czech Industries s.r.o., Ostravská 29, c.p. 305, 747 70 Opava-Komárov, Czech Republic

Pharmachemie B.V., Swensweg 5, Postbus 552, 2003 RN Haarlem, Netherlands

Teva Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary

Teva Pharmaceutical Works Private Limited Company, Táncsics Mihály út 82, 2100 Gödöllo, Hungary

Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: January 2025