Co-bespres

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Co-Bespres (Valsartan + Hydrochlorothiazide Teva)

160 mg + 25 mg, coated tablets

Valsartanum + Hydrochlorothiazidum
Co-Bespres Valsartan + Hydrochlorothiazide Tevaare different trade names for the same medicine.

You should carefully read the contents of the leaflet before using 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.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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, in the form of coated tablets, contains two active substances called valsartan and hydrochlorothiazide. Both of these substances help control high blood pressure (hypertension).

• Valsartanbelongs to a group of medicines called “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 activity 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 the amount of urine, 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 burden on the heart and blood vessels. If left untreated, it can lead to damage to blood vessels in the brain, heart, and kidneys, which can result in stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal values reduces the risk of such disorders.

2. Important information before taking Co-Bespres

When not to take Co-Bespres:

• if the patient is allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (substances with a chemical structure similar to hydrochlorothiazide) or any of the other ingredients of this medicine (listed in section 6).
• if the patient is pregnant over 3 months (it is also recommended to avoid taking Co-Bespres in early pregnancy - see section 2: Pregnancy and breastfeeding).
• if the patient has severe liver disease, damage to the small bile ducts in the liver (biliary cirrhosis) leading to the accumulation of bile in the liver (cholestasis).
• if the patient has severe kidney disease.
• if the patient is unable to produce urine (anuria).
• if the patient is being dialyzed using an artificial kidney.
• if the patient has decreased potassium or sodium levels in the blood or increased calcium levels in the blood, 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, they should not take this medicine and should consult a doctor.

Warnings and precautions

Before starting to take Co-Bespres, the patient should discuss it with their doctor or pharmacist.

• if the patient is taking potassium-sparing medicines, potassium supplements, or salt substitutes containing potassium, or other medicines that increase potassium levels in the blood, such as heparin. It may be necessary for the doctor to monitor potassium levels in the blood.
• if the patient has low potassium levels in the blood.
• if the patient has diarrhea or severe vomiting.
• if the patient is taking high doses of diuretics (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 for starting treatment - kidney function monitoring may also be necessary.
• if the patient has narrowing of the renal artery.
• if the patient has recently had a kidney transplant.
• if the patient has hyperaldosteronism - a disease in which the adrenal glands produce too much of a hormone called aldosterone. In such cases, it is not recommended to take Co-Bespres.
• if the patient has liver or kidney disease.
• if the patient has ever had an allergic reaction, such as angioedema, after taking another medicine (including ACE inhibitors), they should inform their doctor. If such symptoms occur while taking Co-Bespres, the patient should stop taking it immediately and never take it again. See section 4 "Possible side effects".
• if the patient has a 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, has high cholesterol or triglyceride levels in the blood.
• if the patient has had allergic reactions to other blood pressure-lowering medicines of this group (angiotensin II receptor antagonists) or if the patient has an allergy or asthma.
• if the patient has 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 may occur within a few hours to a few weeks after starting to take 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.

and

• if the patient is taking any of the following medicines for high blood pressure:
• an ACE inhibitor (such as enalapril, lisinopril, ramipril), especially if the patient has kidney function disorders related to diabetes.
• aliskiren.
• if the patient has had skin cancer or if an unexpected skin change occurs during treatment. Treatment with hydrochlorothiazide, especially in high doses and for a long time, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). During treatment with Co-Bespres, the patient should protect their skin from sunlight and UV radiation.
• if the patient has had breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient experiences severe shortness of breath or difficulty breathing after taking Co-Bespres, they should seek medical attention immediately.

The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g. potassium) in the 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.
The patient should tell their doctor if they are pregnant, suspect they may be pregnant, or are planning to become pregnant.
It is not recommended to take Co-Bespres during early pregnancy and it should not be taken after 3 months of pregnancy, as it may seriously harm the fetus (see section "Pregnancy and breastfeeding").

Children and adolescents

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

Co-Bespres and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Taking Co-Bespres with certain other medicines may affect treatment. It may be necessary to change the dose, take other precautions, or, in some cases, stop taking one of the medicines. This applies in particular to the following medicines:

• Lithium, a medicine used to treat certain mental illnesses.
• Medicines or substances that may increase potassium levels in the blood, such as potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin.
• Medicines that may decrease potassium levels in the blood, such as diuretics (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 the 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 may cause "torsades de pointes" (heart rhythm disorders), such as anti-arrhythmic medicines (medicines used to treat heart diseases) and certain antipsychotic medicines.
• Medicines that may decrease sodium levels in the 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 noradrenaline or adrenaline.
• Digoxin or other digitalis glycosides (medicines used to treat heart diseases).
• Medicines that may 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 medicines (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 bladder spasms, asthma, motion sickness, muscle cramps, Parkinson's disease, and as an adjunct in anesthesia), such as atropine or biperiden.
• Amantadine (a medicine used to treat Parkinson's disease, as well as 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.
The patient should avoid consuming alcohol until they have consulted their doctor. Alcohol may cause further lowering of blood pressure and (or) increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or is planning to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy

If the patient is pregnant, thinks they may be pregnant, or is planning to have a baby, they should

consult their doctor before taking this medicine.
The doctor will usually recommend stopping Co-Bespres before planned pregnancy or immediately after confirmation of pregnancy and recommend taking another medicine instead of Co-Bespres.
It is not recommended to take Co-Bespres during early pregnancy and it should not be taken after 3 months of pregnancy, as it may seriously harm the fetus.
Breastfeeding

If the patient is breastfeeding or plans to start breastfeeding, they should

consult their doctor before taking this medicine.
It is not recommended to take Co-Bespres during breastfeeding. The doctor may recommend taking another medicine, especially when breastfeeding a newborn or premature baby.

Driving and using machines

Before driving a vehicle, using tools, operating machinery, or performing other activities that require concentration, the patient should be aware of their 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 coated tablet, which means it is considered "sodium-free".

3. How to take Co-Bespres

This medicine should always be taken as directed by the doctor. This will help to achieve the best results and reduce the risk of side effects. If the patient has any doubts, they should consult their doctor or pharmacist.
Co-Bespres is available in the following doses: (80 mg + 12.5 mg), (160 mg + 25 mg).
People with high blood pressure often do not notice any symptoms associated with it.
Many of them feel quite well. Therefore, it is especially important to attend follow-up appointments with the doctor, even if they feel well.
The doctor will inform the patient how many Co-Bespres tablets to take. Depending on the patient's response to treatment, the doctor may recommend a higher or lower dose.

• The recommended dose of Co-Bespres is usually one tablet per day.
• The patient should not change the dose or stop treatment without consulting their 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, the patient should lie down and contact their doctor immediately.
In case of accidental ingestion of too many tablets, the patient should contact their doctor, pharmacist, or go to the emergency department of the nearest hospital.

Missing a dose of Co-Bespres

If the patient misses a dose, they should take it as soon as they remember. However, if it is almost time for the next dose, they should skip the missed dose.
The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Co-Bespres

Stopping treatment with Co-Bespres may cause blood pressure to worsen. The patient should not stop taking the medicine unless their doctor recommends it.

If the patient has any further doubts about taking this medicine, they should consult their 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:

• the patient should contact their doctor immediately if they 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 a rash, redness of the skin, blistering of the lips, eyes, or mouth, 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 patients).

In case of any of these symptoms, the patient should stop taking Co-Bespres and contact their doctor immediately (see section 2 "Warnings and precautions").

Other side effects include:

Uncommon (may affect less than 1 in 100 patients)

• 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, rare 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 patients)

• 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, muscle tremors, and (or) convulsions in severe cases)
• low potassium levels in the blood (sometimes with muscle weakness, muscle cramps, heart rhythm disorders)
• low white blood cell count (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 patients)

• vertigo
• abdominal pain.

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

• blistering (symptom of bullous dermatitis)
• rash with itching or without, accompanied by some of the following 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 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, muscle tremors, and (or) convulsions in severe cases).

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

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

Common (may affect less than 1 in 10 patients)

• 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 patients)

• 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, discomfort in the stomach or intestines, liver disorders, which may occur with yellowing of the skin or 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 patients)

• vasculitis with symptoms such as rash, purple-red spots, fever
• rash, itching, hives, difficulty breathing or swallowing, dizziness (allergic reactions)
• rash on the face, joint pain, muscle disorders, 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, rapid breathing (hypochloremic alkalosis)
• low levels of various blood cells.

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 function disorders or kidney failure)
• rash, redness of the skin, blistering of the lips, eyes, or mouth, 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 the patient experiences any side effects, including any not listed in the leaflet, they should tell their 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
Reporting side effects will help to gather more information on the safety of the medicine.

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. The expiry date refers to the last day of the 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. The patient should ask their 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 160 mg of valsartan and 25 mg of hydrochlorothiazide.
• Other ingredients of the medicine are: colloidal anhydrous silica, sodium carboxymethylcellulose (type A), crospovidone, microcrystalline cellulose, corn starch, magnesium stearate. The tablet coating Opadry 03F26816 Browncontains: hypromellose 2910 6cP, macrogol 8000, talc, titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172), iron oxide yellow (E 172).

What Co-Bespres looks like and contents of the pack

Round, brown, coated tablets, with the number "93" embossed on one side and "7430" on the other.
The product is available in packs of: 14, 28 tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

Teva Pharma – Produtos Farmacêuticos, Lda.
Lagoas Park, Edifício 5A, Piso 2
2740-245 Porto Salvo
Portugal

Manufacturer:

Teva Czech Industries s.r.o., Ostravská 29, č.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 Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warszawa

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warszawa
Authorization number in Portugal, the country of export:5148457
5148440
5148465
Parallel import authorization number:468/16

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

Member State

Date of leaflet approval: 19.04.2023
[Information about the trademark]