Co-bespres

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Co-Bespres (Valsartan + Hydrochlorothiazide Teva)
160 mg + 25 mg, coated tablets
Valsartanum + Hydrochlorothiazidum
Co-Bespres and Valsartan + Hydrochlorothiazide Teva are different trade names for the same
medicinal product.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms appear identical.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

Co-Bespres tablets contain two active substances called valsartan and hydrochlorothiazide. Both 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 activity of angiotensin II, resulting in the widening of blood vessels and a reduction in blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also referred to as "diuretics"). Hydrochlorothiazide increases urine output, which also helps lower blood pressure.

Co-Bespres is used in the treatment of high blood pressure that cannot be adequately controlled with only one of the active substances.
High blood pressure increases the workload on the heart and blood vessels. If left untreated, it may lead to damage of blood vessels in the brain, heart, and kidneys, potentially resulting in 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, sulfonamide derivatives (substances chemically similar to hydrochlorothiazide), or 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 advisable to avoid using 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 (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, this medicine must not be used and the patient should
contact a doctor.
Warnings and precautions
Before starting treatment with 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. Your doctor may need to monitor your 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 (water pills).

• 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 advice regarding starting treatment – kidney function monitoring may also be necessary.

• if the patient has renal artery stenosis (narrowing of the artery to the kidney).

• 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 cases, 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, known as angioedema, after taking another medicine (including ACE inhibitors), the patient should inform the doctor. If such symptoms occur while taking Co-Bespres, the patient must stop taking it immediately and must never take it again. See 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 had allergic reactions after taking other blood pressure-lowering medicines belonging to this group (angiotensin II receptor antagonists), or if the patient has allergies or asthma.

• if the patient experiences vision changes or eye pain. These may be symptoms of fluid accumulation in the uvea (excessive fluid accumulation between the choroid and sclera) or increased intraocular pressure, which may occur within hours to weeks after starting Co-Bespres. If left untreated, this may lead to complete vision loss. The risk of such disorders is higher in patients allergic to penicillin or sulfonamides.

• 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 dysfunction related to diabetes.

• aliskiren.

• if the patient has previously had skin cancer or develops unexpected skin changes during treatment. Treatment with hydrochlorothiazide, especially at high doses over a prolonged period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. While taking Co-Bespres, the patient should protect the skin from sunlight and UV radiation.

• if the patient has previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient develops severe shortness of breath or difficulty breathing 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 the information under the heading "When not to use Co-Bespres".
Co-Bespres may increase skin sensitivity to sunlight.
Tell your doctor if you are pregnant, suspect you may be pregnant, or are 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").
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 (water pills), corticosteroids, laxatives, ACTH (adrenocorticotropic 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 conditions) 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 blood pressure-lowering medicines, including methyldopa, angiotensin-converting enzyme (ACE) inhibitors (e.g. 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 digitalis glycosides (medicines used to treat heart conditions).
• 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 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 in the treatment or prevention of certain viral diseases).
• Cholestyramine and colestipol (medicines mainly used to treat high blood lipid levels).
• Cyclosporine, a medicine used in patients with transplanted organs to prevent organ rejection.
• Alcohol, sleeping pills, 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 discussed with 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, breastfeeding, suspects she may be pregnant, or is planning to have a baby, 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 baby, she should consult a doctor before using this medicine. The doctor will usually advise stopping Co-Bespres before a planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative 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.

Breast-feeding

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

Driving and using machines
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, which means the medicine is considered "sodium-free".

3. How to use Co-Bespres

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

Co-Bespres is available in the following strengths: (80 mg + 12.5 mg), (160 mg + 25 mg).

People with high blood pressure often do not experience any related symptoms and may feel quite well. For this reason, it is especially 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, the doctor may adjust your dose to a higher or lower strength.

• 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 may be taken with or without food.
• Swallow the tablet with a glass of water.

Taking more Co-Bespres than prescribed
If severe dizziness and/or fainting occurs, lie down immediately and contact your doctor without delay.
If an overdose is taken by accident, contact a doctor, pharmacist, or go to the nearest hospital's emergency department.

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

Stopping Co-Bespres treatment
Stopping treatment with Co-Bespres may cause worsening of hypertension. 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 increased pressure (possible signs of fluid accumulation in the vascular membrane surrounding the eye – excessive fluid accumulation between the choroid and sclera – or acute angle-closure glaucoma).

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

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

These adverse reactions are very rare (may affect fewer than 1 in 10,000 patients).
If any of these symptoms occur, discontinue use of Co-Bespres immediately and contact your doctor
(see section 2 "Warnings and precautions").
Other adverse reactions include:
Not common (may affect fewer than 1 in 100 patients)

• cough
• low blood pressure
• feeling of "emptiness" in the head
• dehydration (with sensation of thirst, dryness of the oral mucosa and tongue, infrequent urination, dark urine colour, 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
• diarrhoea
• joint pain.

Frequency unknown (frequency cannot be estimated from the available data)

• difficulty breathing
• significantly reduced urine output
• low sodium levels in the blood (which may cause fatigue, confusion, muscle twitching and (or) seizures in severe cases)
• low potassium levels in the blood (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 (vertigo)
• abdominal pain.

Frequency unknown (frequency cannot be estimated from the available data)

• blister formation (symptom of bullous dermatitis)
• skin rash with or without itching, accompanied by some of the following objective and 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 potassium levels in the blood (sometimes with muscle cramps, cardiac arrhythmias)
• allergic reactions (with symptoms such as rash, itching, urticaria, breathing or swallowing difficulties, dizziness)
• swelling, mainly of the face and throat; rash; itching
• increased liver enzyme activity
• decreased haemoglobin and haematocrit values (both parameters may indicate anaemia in severe cases)
• renal failure
• low sodium levels in the blood (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 potassium levels in the blood
• increased blood lipid levels

Common (may affect fewer than 1 in 10 patients)

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

Rare (may affect fewer 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 glucose levels
• presence of glucose in the urine
• worsening of metabolic status in diabetes
• constipation, diarrhoea, 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 bruising under the skin)
• 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, skin 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 oedema)
• pale skin, fatigue, shortness of breath, dark urine (haemolytic anaemia)
• fever, sore throat or mouth ulcers due to infections (leukopenia)
• confusion, fatigue, tremor and muscle cramps, rapid breathing (hypochloraemic alkalosis)
• absence or low levels of various blood cells.

Frequency unknown (frequency cannot be estimated from the available data)

• weakness, bruising and frequent infections (aplastic anaemia)
• significantly reduced urine output (possible signs of kidney function disorders or renal failure)
• rash, redness of the skin, formation of blisters on the lips, eyelids or in the mouth, skin peeling, fever (possible signs of erythema multiforme)
• muscle cramps
• fever
• weakness (asthenia)
• skin and lip tumours (non-melanoma skin cancers).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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
Reporting adverse reactions allows additional information on the safety of the medicine to be collected.

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 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. This will help protect
  the environment.

6. Contents of the packaging and other information

What Co-Bespres contains

• The active substances in this medicine are: valsartan and hydrochlorothiazide. Each tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.
• Other ingredients in the medicine are: colloidal anhydrous silica, sodium carboxymethyl starch (type A), crospovidone, microcrystalline cellulose, corn starch, magnesium stearate. The tablet coating Opadry 03F26816 Brown contains: hypromellose 2910 6cP, polyethylene glycol 8000, talc, titanium dioxide (E 171), red iron oxide (E 172), black iron oxide (E 172), yellow iron oxide (E 172).

What Co-Bespres looks like and contents of the pack
Round, brown film-coated tablets, with the number "93" embossed on one side and "7430" on the other side.
The product is available in packs of: 14, 28 tablets.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation 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, The 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, Poland
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warszawa
Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warszawa
Poland
Marketing authorisation number in Portugal, the country of export: 5148457
Parallel import authorisation number: 468/16
This medicinal product is authorised for marketing in the European Economic Area under the following names