BISOPROLOL/HYDROCHLOROTHIAZIDE TEVA 10/25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Bisoprolol/Hydrochlorothiazide Teva 10 mg/25 mg Film-Coated Tablets EFG

bisoprolol hemifumarate/hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Bisoprolol/Hydrochlorothiazide Teva and what is it used for.
2. What you need to know before you take Bisoprolol/Hydrochlorothiazide Teva
3. How to take Bisoprolol/Hydrochlorothiazide Teva.
4. Possible side effects.
5. Storing Bisoprolol/Hydrochlorothiazide Teva

1. Contents of the pack and further information

1. What is Bisoprolol/Hydrochlorothiazide Teva and what is it used for

This medication consists of a selective beta-receptor blocker (bisoprolol) and a thiazide diuretic (a medication to remove water from the body) (hydrochlorothiazide).

It is used to treat high blood pressure (essential hypertension) in adult patients whose blood pressure is not sufficiently controlled with bisoprolol or hydrochlorothiazide alone.

2. What you need to know before you take Bisoprolol/Hydrochlorothiazide Teva

Do not take Bisoprolol/Hydrochlorothiazide Teva

• If you are allergic to bisoprolol or hydrochlorothiazide or other thiazides, sulfonamides or any of the other ingredients of this medication (listed in section 6).
• If you have acute heart failure or worsening (decompensation) of existing heart failure that requires treatment with intravenous substances to strengthen heart action.
• If you have shock caused by heart function disorders (cardiogenic shock).
• If you have significant heart rhythm disorders (second and third degree AV block without a pacemaker, sick sinus syndrome, sinoatrial block).
• If you have a very slow heart rate (less than 60 beats per minute) before starting treatment.
• If you have a tendency to severe bronchial asthma.
• If you have severe blood circulation problems (which can cause tingling in fingers and toes or turn them pale or blue) (Raynaud's syndrome).
• If you have an adrenal gland tumor (pheochromocytoma) and are not being treated.
• If you have excessive blood acidity (metabolic acidosis).
• If you have a severe kidney function disorder (renal insufficiency) with little or no urine production (creatinine clearance less than or equal to 30 ml/minute or serum creatinine above 1.8 mg/100 ml).
• If you have acute kidney inflammation (glomerulonephritis).
• If you have clouding of consciousness caused by severe liver disease (hepatic coma/precoma).
• If you have potassium deficiency (hypokalemia) that does not respond to treatment.
• If you have severe sodium deficiencies (hyponatremia).
• If you have high serum calcium levels (hypercalcemia).
• If you have gout.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bisoprolol/Hydrochlorothiazide Teva:

• If you have heart failure (treatment of chronic stable heart failure should start with a gradual increase of bisoprolol only).
• If you have bronchial asthma or chronic obstructive pulmonary disease.
• If you are going to receive general anesthesia (e.g., for surgery).
• If you have diabetes mellitus with strong variations in blood glucose values; symptoms of very low blood glucose (hypoglycemia) may be masked.
• If you are on a very strict fast.
• During desensitization treatment.
• If you have minor heart rhythm disorders (first degree AV block).
• If you have blood supply disorders to the heart that cause chest pain and result from spasmodic constrictions of the coronary arteries (Prinzmetal's angina).
• If you have blood circulation problems (it is possible that symptoms may worsen, especially at the start of treatment).
• If your blood volume is reduced (hypovolemia).
• If you have a liver function disorder.
• If you are an elderly person.
• If you have excessive uric acid levels in the blood (hyperuricemia), as the risk of gout attacks may increase.
• If you have or have had psoriasis.
• If you have a thyroid problem. Bisoprolol/Hydrochlorothiazide Teva may hide the symptoms of an overactive thyroid.
• If you have an adrenal gland tumor (pheochromocytoma) and are being treated.
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Bisoprolol/Hydrochlorothiazide Teva.

If you have bronchial asthma or other chronic obstructive pulmonary disorders that may cause symptoms, your doctor may need to increase your dose of bronchodilators (beta-sympathomimetics) during your treatment with Bisoprolol/Hydrochlorothiazide Teva.

As with other beta-blockers, bisoprolol may increase both sensitivity to allergens and the severity of allergic reactions (anaphylactic reactions). This also applies to desensitization therapy. Adrenaline treatment may not always produce the expected therapeutic effect.

If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Bisoprolol/Hydrochlorothiazide Teva, seek medical attention immediately.

If you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and can occur within hours to weeks after taking Bisoprolol/Hydrochlorothiazide Teva. If left untreated, this can lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamide, you may be at higher risk of developing it.

You should not stop taking beta-blocker treatment (e.g., bisoprolol) abruptly unless it is urgently necessary.

If you are going to receive general anesthesia, you should inform the anesthesiologist about your beta-blocker treatment. It is currently recommended to continue therapy, as it may favorably influence heart rhythm and circulatory disorders that may occur during surgery. If it is considered necessary to withdraw beta-blocker treatment before the intervention, it should be done gradually and completed 48 hours before anesthesia.

This medication may cause skin reactions to sunlight such as rash, skin redness, itching (this is called photosensitivity). If this occurs, you should protect your skin from sun exposure (with sunscreens, clothing, avoiding sun). In cases of severe photosensitivity, it may be necessary to interrupt treatment with Bisoprolol/Hydrochlorothiazide Teva, but you should consult your doctor first.

Note

During treatment with bisoprolol/hydrochlorothiazide, serum electrolytes (especially potassium, sodium, and calcium), creatinine, and urea, blood lipids (cholesterol and triglycerides), uric acid, and blood glucose should be regularly monitored to detect disturbances of the hydroelectrolytic balance, especially hyponatremia, hypochloremic alkalosis, and hypokalemia.

A disturbance of the acid-base balance in the blood may worsen (metabolic alkalosis) due to a disturbance of fluid and electrolyte balance.

Cases of acute inflammation of the gallbladder (cholecystitis) have been reported in patients with gallstones.

If you wear contact lenses, you should know that bisoprolol can reduce tear production.

Effects in case of misuse for doping purposes

Competing athletes should be aware that this medication contains an agent that can give a positive reaction in doping tests.

Children and adolescents

Bisoprolol/Hydrochlorothiazide Teva is not recommended for children.

Other medications and Bisoprolol/Hydrochlorothiazide Teva

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medications.

The following medications are not recommended for concomitant use with bisoprolol/hydrochlorothiazide:

• Calcium antagonists such as verapamil or diltiazem, which are used to treat certain forms of heart disease: heart rhythm disorders and heart muscle weakness may occur.
• Antihypertensive agents with central action (such as clonidine, alpha-methyldopa, moxonidine, reserpine): a further reduction in heart rate and cardiac output, as well as vasodilation, may occur. Abrupt withdrawal may cause an excessive increase in blood pressure. Central antihypertensive agents should only be withdrawn when treatment with this medication has been previously interrupted for a few days.
• Lithium, which is used to treat depression: reduced elimination of lithium may result in more severe damage to the nervous and cardiovascular systems.

Caution should be exercised if the following medications are used concomitantly with bisoprolol/hydrochlorothiazide:

• Calcium antagonists such as nifedipine and amlodipine (called dihydropyridines), which are used to treat certain forms of heart disease: an excessive drop in blood pressure may occur, especially at the start of treatment. In patients with latent heart failure, treatment with beta-blockers at the same time may lead to the manifestation of heart failure.
• ACE inhibitors such as captopril and enalapril, as well as angiotensin II antagonists, which are used to treat high blood pressure and other heart diseases: an excessive drop in blood pressure and/or acute renal failure may occur at the start of treatment with ACE inhibitors.
• Medications used to treat heart rhythm disorders (antiarrhythmic agents) such as disopyramide, quinidine, amiodarone, and sotalol: the effects of bisoprolol/hydrochlorothiazide and antiarrhythmic agents on heart function may be additive. Potentially fatal and severe heart rhythm disorders (called torsade de pointes) may develop.
• Astemizole (an antihistamine), intravenous erythromycin (an antibiotic), halofantrine (used to treat malaria), pentamidine (used to treat parasitic infestations), sparfloxacin (an antibiotic), terfenadine (an antihistamine), vincamine (used to treat certain forms of cerebral disease): severe heart rhythm disorders may develop.
• Medications called parasympathomimetics, including tacrine, which are used in the treatment of Alzheimer's disease: risk of slow heart rate (bradycardia).
• Other beta-blockers, including those contained in eye drops for the treatment of glaucoma, which are used to treat heart or eye diseases, have an additive effect.

• Insulin or other medications that lower blood glucose (sulfonylureas), which are used to treat diabetes: the effect of these medications may increase. Signs of low blood glucose (hypoglycemia) may be masked or less pronounced, especially rapid heartbeat (tachycardia).
• Anesthetics: before undergoing general anesthesia, inform your anesthesiologist that you are taking bisoprolol/hydrochlorothiazide because beta-blocker medications can interact with other medications and influence how your body reacts to this situation. If possible, it is recommended that you continue treatment with beta-blockers before, during, and after surgery.
• Medications such as digitalis, which are used to treat heart diseases such as congestive heart failure: any potassium or magnesium deficiency may make digitalis side effects more likely to occur.
• Inhibitors of prostaglandin synthesis such as acetylsalicylic acid, which are used to relieve pain: the blood pressure-lowering effect of bisoprolol/hydrochlorothiazide may be reduced. The adverse effects of high doses of salicylate medications on the central nervous system may increase.
• Non-steroidal anti-inflammatory medications such as ibuprofen, which are used to relieve pain: in patients with reduced blood volume (hypovolemia), acute renal failure may occur.
• Ergotamine derivatives such as bromocriptine, which are used in diseases such as Parkinson's disease: any existing blood circulation disorder may worsen.
• Medications called beta-sympathomimetics that may be used in the treatment of asthma or chronic obstructive pulmonary diseases: the effects of both treatments may be weakened.
• Higher doses of adrenaline than usual may be necessary to treat allergic reactions.
• Sympathomimetics that activate both beta and alpha-adrenergic receptors (e.g., adrenaline, noradrenaline): combination with bisoprolol may cause an increase in blood pressure and exacerbate intermittent claudication.
• Tricyclic antidepressants such as amitriptyline, barbiturates such as phenobarbital, phenothiazines such as chlorpromazine, which are all used in the treatment of diseases such as depression, and other medications that lower high blood pressure: an increase in the blood pressure-lowering effect is possible.
• The effect of medications that reduce uric acid may be weakened if bisoprolol/hydrochlorothiazide is taken at the same time.
• Glucocorticoids such as hydrocortisone or dexamethasone (used in the treatment of inflammation), ACTH (used in the treatment of multiple sclerosis or rheumatoid arthritis), carbenoxolone (used to treat ulcers), amphotericin B (an antibiotic), furosemide (a diuretic), or laxatives: potassium loss may increase.
• Cytostatics (e.g., cyclophosphamide, fluorouracil, methotrexate), which may be used in the treatment of cancer: an increase in bone marrow toxicity can be expected.
• Cholestyramine, colestipol, which are used in the treatment of high cholesterol: these medications reduce the extent to which the body absorbs hydrochlorothiazide.
• Methyldopa, which may be used to treat high blood pressure: in isolated cases, hemolysis (increase in hemoglobin in the blood as it is separated from red blood cells) has been reported as a result of antibody formation to hydrochlorothiazide.
• Mefloquine, which is used to treat malaria: the risk of a decrease in heart rate increases.
• Monoamine oxidase inhibitors (MAOIs) such as moclobemide or phenelzine, except MAO-B inhibitors such as selegiline, which are used in the treatment of conditions such as depression: excessive decreases or increases in blood pressure may occur.

Bisoprolol/Hydrochlorothiazide Teva with food and drinks

During your treatment with Bisoprolol/Hydrochlorothiazide Teva, make sure to drink enough fluids and eat potassium-rich foods (e.g., bananas, vegetables, nuts) to compensate for potassium loss.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medication.

Pregnancy

Tell your doctor if you are pregnant or think you may be. Normally, your doctor will advise you to take a different medication instead of Bisoprolol/Hydrochlorothiazide Teva, as bisoprolol/hydrochlorothiazide is not recommended during pregnancy. This is because bisoprolol/hydrochlorothiazide crosses the placenta, and its use after the third trimester of pregnancy may cause potentially harmful fetal and neonatal effects.

Breastfeeding

Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Bisoprolol/Hydrochlorothiazide Teva is not recommended for mothers who are breastfeeding.

Fertility

No data are available on the use of the combination preparation and its effect on fertility in humans. Bisoprolol and hydrochlorothiazide did not show effects on fertility in animal studies.

Driving and using machines

Although Bisoprolol/Hydrochlorothiazide Teva normally does not have any effect on the ability to drive or use machines, you should be careful when performing these activities, especially at the start of treatment, if you change your medication, or if you have consumed alcohol. Sometimes dizziness may occur with this medication. These individual reactions to the medication can impair the ability to drive or use machines.

3. How to take Bisoprolol/Hydrochlorothiazide Teva

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

For oral use.

Individual dose adjustment with the separate substances (i.e., bisoprolol and hydrochlorothiazide) is recommended.

A direct switch from monotherapy to fixed-dose combination is possible if the doctor considers it justified.

The recommended dose is one 5 mg/12.5 mg or half of 10 mg/25 mg tablet once a day. Your doctor may decide to increase the dose to two 5 mg/12.5 mg or one 10 mg/25 mg tablets once a day depending on your response to treatment.

Patient with renal disease, elderly patients

In case of impaired renal function, the elimination of the hydrochlorothiazide component of bisoprolol/hydrochlorothiazide is reduced. Your doctor will decide on the most suitable dose for you.

Method of administration

If possible, you should take this medication in the morning with breakfast and swallow the tablet whole, without chewing, with some liquid.

The tablet can be divided into equal doses.

Duration of administration

Your doctor will indicate the duration of your treatment.

Use in children and adolescents

Bisoprolol/Hydrochlorothiazide Teva is not recommended in children due to the lack of clinical experience.

If you take more Bisoprolol/Hydrochlorothiazide Teva than you should

Seek medical attention. He/she may decide on the measures that are necessary, depending on the degree of overdose. In case of overdose, you should discontinue treatment with Bisoprolol/Hydrochlorothiazide Teva.

The most common signs of a bisoprolol/hydrochlorothiazide overdose are slow heart rate (bradycardia), difficulty breathing (bronchospasm), severe drop in blood pressure, acute heart failure, and low blood sugar (hypoglycemia). Other signs of acute or chronic hydrochlorothiazide overdose may include dizziness, nausea, drowsiness, decreased blood volume (hypovolemia), and hypotension.

In case of overdose, treatment with this medication should be discontinued after consulting your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take Bisoprolol/Hydrochlorothiazide Teva tablets

Do not take a double dose to make up for forgotten doses.

Continue taking Bisoprolol/Hydrochlorothiazide Teva according to the instructions given in this leaflet or as prescribed by your doctor.

If you stop taking Bisoprolol/Hydrochlorothiazide Teva

Do not stop or discontinue your treatment with Bisoprolol/Hydrochlorothiazide Teva without consulting your doctor first.

You should not stop your treatment with this medication abruptly, as it may worsen your heart failure.

Your treatment should be discontinued gradually (reducing the dose by half over a period of 7-10 days), as abrupt discontinuation of treatment may lead to acute worsening of the disease.

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

4. Possible side effects

Like all medications, this medication can have side effects, although not everyone gets them.

If you experience the following effects, do not take Bisoprolol/Hydrochlorothiazide Teva and visit your doctor or go to the nearest hospital immediately.

• difficulty breathing and swelling of the legs, which is a symptom of worsening heart failure (may affect up to 1 in 100 people),
• respiratory problems and wheezing (bronchospasm), especially if you have asthma or chronic bronchial disease (may affect up to 1 in 100 people),
• severe abdominal and back pain with a feeling of discomfort, which can be symptoms of a condition called pancreatitis (may affect up to 1 in 100 people),
• symptoms such as flu and fever, which can be signs of decreased white blood cells (leukopenia) (may affect up to 1 in 1,000 people) or low granulocyte count in the blood (agranulocytosis) (may affect up to 1 in 10,000 people),
• easy bruising and nosebleeds, which can be symptoms of low platelet count (thrombocytopenia) (may affect up to 1 in 1,000 people),
• abdominal pain, loss of appetite, yellowing of the whites of the eyes and skin, dark urine, which can be caused by liver inflammation (hepatitis) (may affect up to 1 in 1,000 people),
• yellowing of the skin and eyes (jaundice) (may affect up to 1 in 1,000 people),
• allergic reactions; itching, redness, skin rash, sun-sensitive skin rash (photodermatitis), bleeding in the skin (purpura), hives; severe allergic reactions, which can include swelling of the face, neck, tongue, mouth, or throat, or difficulty breathing (may affect up to 1 in 1,000 people),
• chest pain (may affect up to 1 in 10,000 people),
• psoriasis (a disease in which silver scales develop on the skin) or skin rashes like psoriasis, worsening of existing psoriasis (may affect up to 1 in 10,000 people),
• skin diseases with scaly red patches on the nose and cheeks (lupus erythematosus) (may affect up to 1 in 10,000 people),
• acute difficulty breathing (the signs include severe difficulty breathing, fever, weakness, and confusion) (very rare, may affect up to 1 in 10,000 people).

Other possible side effects

Frequent (may affect up to 1 in 10 people)

• some side effects can only be seen in a blood test, such as elevated levels of fats in the blood (triglycerides, cholesterol), elevated blood sugar (hyperglycemia), and elevated levels of uric acid in the blood (hyperuricemia, which can be associated with gout),
• glucose in the urine (glucosuria),
• fluid and electrolyte balance disorders, especially low potassium levels in the blood (hypokalemia, which can cause fatigue, exhaustion, muscle weakness, abnormal sensations in the limbs (paresthesias), paralysis, apathy, smooth muscle weakness with constipation, excessive gas accumulation in the gastrointestinal tract (flatulence), or heart rhythm disturbances, intestinal obstruction, alterations in consciousness, and coma),
• low sodium levels (hyponatremia, which can cause fatigue and confusion, muscle twitches, seizures, or coma), low magnesium levels in the blood (hypomagnesemia, which can be associated with muscle problems), low chloride levels in the blood (hypochloremia),
• high calcium levels in the blood (hypercalcemia, causing abdominal pain, nausea, and vomiting, constipation, loss of appetite, excessive thirst, excessive urination, fatigue, weakness, and weight loss),
• increased acid levels in the blood (metabolic acidosis, which can be associated with fatigue, nausea, vomiting, rapid breathing),
• fatigue*,
• dizziness*,
• headache*,
• feeling of cold or numbness in the limbs,
• nausea, vomiting, diarrhea, constipation.

Infrequent (may affect up to 1 in 100 people)

• exhaustion,
• sleep disorders,
• depression,
• slow heart rate (bradycardia),
• heart rhythm disorders (called AV conduction disorders),
• low blood pressure, which can be associated with postural changes and can be characterized by feelings of fainting and weakness when standing up after sitting (orthostatic hypotension),
• loss of appetite,
• abdominal pain,
• some side effects can only be seen in a blood test: increased levels of certain molecules in the blood (amylases, creatinine, and urea),
• muscle weakness and cramps.

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

• nightmares, hallucinations,
• reduced tear flow (take this into account if you wear contact lenses),
• visual disturbances,
• hearing disturbances,
• circulatory collapse (syncope),
• allergic rhinitis (runny nose),
• some side effects can only be seen in a blood test: increased levels of certain liver enzymes in the blood (AST, ALT),
• erectile dysfunction.

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

• some side effects can only be seen in a blood test, such as metabolic alkalosis,
• conjunctivitis (inflammation of the lining around the eye),
• hair loss.

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

• skin and lip cancer (non-melanoma skin cancer),
• loss of vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion or acute angle-closure glaucoma)),
• interstitial lung disease.

*These signs and symptoms appear especially at the start of treatment. They are usually mild and normally disappear within one or two weeks.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System, https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Bisoprolol/Hydrochlorothiazide Teva

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging and blister after "EXP". The expiration date is the last day of the month indicated.

Do not store above 30°C. Store in the original packaging.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Bisoprolol/Hydrochlorothiazide Teva

• The active ingredients are bisoprolol hemifumarate and hydrochlorothiazide.
• Each tablet contains 10 mg of bisoprolol hemifumarate and 25 mg of hydrochlorothiazide.
• The other ingredients are:
• Core: cornstarch (gluten-free), microcrystalline cellulose, anhydrous colloidal silica, anhydrous calcium hydrogen phosphate, magnesium stearate.
• Coating: hypromellose, polysorbate 80, macrogol 400, brilliant blue FCF aluminum lake E133, yellow quinoline aluminum lake E104, and titanium dioxide E171.

Appearance of Bisoprolol/Hydrochlorothiazide Teva and package contents

Your tablets are blue, film-coated, round, scored on one side, and engraved with a "B" on the left side of the score and an "H" on the right side of the score. The other side is engraved with a "10". They are available in blister packs containing 28, 30, 50, 56, and 100 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas, Madrid (Spain)

Manufacturer

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13

H-4042 Debrecen

Hungary

or

Pharmachemie B.V.

Swensweg 5, Postbus 552,

2003 RN Haarlem

Netherlands

or

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80

31-546 Cracow

Poland

This medication is registered in the Member States of the European Economic Area under the following names:

BE: Co-Bisoprolol TEVA 10 mg / 25 mg film-coated tablets

DE: Bisoprolol-TEVA® comp. 10 mg / 25 mg film-coated tablets

ES: Bisoprolol/HCTZ TEVA 10/25mg film-coated tablets EFG

Date of the last revision of this leaflet:April 2024

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information on this medication by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69667/P_69667.html

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