Bisoprolol/hydrochlorothiazide Teva 10/25 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

Bisoprolol/Hydrochlorothiazide Teva 10 mg/25 mg film-coated tablets EFG

bisoprolol hemifumarate/hydrochlorothiazide

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

3. How to take Bisoprolol/Hydrochlorothiazide Teva.

4. Possible side effects.

5. How to store Bisoprolol/Hydrochlorothiazide Teva.

6. Contents of the pack and other information

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

This medicine contains a selective beta-blocker (bisoprolol) and a thiazide diuretic (a medicine 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 adequately controlled with bisoprolol or hydrochlorothiazide alone.

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

Do not take Bisoprolol/Hydrochlorothiazide Teva

• If you are allergic to bisoprolol or hydrochlorothiazide, other thiazides, sulfonamides, or any of the other ingredients of this medicine (listed in section 6).
• If you have acute heart failure or worsening (decompensation) of existing heart failure requiring treatment with intravenous agents to strengthen heart function.
• If you have shock caused by heart dysfunction (cardiogenic shock).
• If you have severe disturbances in heart rhythm (second- or 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 towards severe bronchial asthma.
• If you have severe circulatory problems (which may cause tingling in fingers and toes or make them pale or blue) (Raynaud's syndrome).
• If you have an adrenal gland tumor (pheochromocytoma) and are not being treated for it.
• If you have excessive acidity in the blood (metabolic acidosis).
• If you have severe kidney function impairment (renal failure) with little or no urine production (creatinine clearance ≤ 30 ml/min or serum creatinine above 1.8 mg/100 ml).
• If you have acute inflammation of the kidneys (glomerulonephritis).
• If you have impaired consciousness due to severe liver disease (hepatic coma/precoma).
• If you have potassium deficiency (hypokalemia) unresponsive to treatment.
• If you have severe sodium deficiency (hyponatremia).
• If you have elevated serum calcium levels (hypercalcemia).
• If you suffer from gout.

Warnings and precautions

Consult your doctor or pharmacist before taking Bisoprolol/Hydrochlorothiazide Teva:

• If you have heart failure (treatment of stable chronic heart failure [weakened heart muscle] should begin with gradual dose escalation of bisoprolol alone).
• If you suffer from bronchial asthma or obstructive airway disease.
• If you are going to receive general anesthesia (e.g., for surgery).
• If you have diabetes mellitus with significant fluctuations in blood glucose levels; symptoms of low blood sugar (hypoglycemia) may be masked.
• If you are on a very strict fast.
• During desensitization therapy.
• If you have minor disturbances in heart rhythm (first-degree AV block).
• If you have reduced blood supply to the heart causing chest pain due to spasmodic constriction of coronary arteries (Prinzmetal's angina).
• If you have circulatory problems (symptoms may worsen, especially at the beginning of treatment).
• If your blood volume is reduced (hypovolemia).
• If you have impaired liver function.
• If you are elderly.
• If you have high levels of uric acid in the blood (hyperuricemia), as this may increase the risk of gout attacks.
• If you have or have had psoriasis.
• If you have a thyroid disorder. Bisoprolol/Hydrochlorothiazide Teva may mask symptoms of an overactive thyroid.
• If you have an adrenal gland tumor (pheochromocytoma) and are being treated for it.
• If you have had skin cancer or 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 non-melanoma skin and lip cancer. Protect your skin from sun and UV exposure while taking Bisoprolol/Hydrochlorothiazide Teva.

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

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

If you have previously experienced respiratory or lung problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide, and if you develop dyspnea or severe breathing difficulty after taking Bisoprolol/Hydrochlorothiazide Teva, consult your doctor immediately.

If you experience vision loss or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours to weeks after taking Bisoprolol/Hydrochlorothiazide Teva. If untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk.

Do not abruptly stop treatment with beta-blockers (e.g., bisoprolol) unless absolutely necessary.

If you are to receive general anesthesia, inform the anesthesiologist about your beta-blocker treatment. Continuing therapy is currently recommended, as it may favorably influence heart rhythm and circulatory disturbances during surgery. If discontinuation of beta-blockers before surgery is considered necessary, it should be done gradually and completed approximately 48 hours before anesthesia.

This medicine may cause skin reactions to sunlight such as rash, redness, or itching (known as photosensitivity). If this occurs, protect your skin from sun exposure (using sunscreen creams, clothing, avoiding sunlight). In cases of severe photosensitivity, treatment with Bisoprolol/Hydrochlorothiazide Teva may sometimes need to be discontinued, but you should consult your doctor first.

Note

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

Acid-base imbalance in the blood may worsen (metabolic alkalosis) due to disturbances in fluid and electrolyte balance.

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

If you wear contact lenses, be aware that bisoprolol may reduce tear production.

Effects in case of misuse for doping purposes

Athletes in competition should be aware that this medicine contains a substance that may lead to a positive doping test.

Children and adolescents

Bisoprolol/Hydrochlorothiazide is not recommended for use in children.

Other medicines and Bisoprolol/Hydrochlorothiazide Teva

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Concomitant use of the following medicines with bisoprolol/hydrochlorothiazide is not recommended:

• Calcium antagonists such as verapamil or diltiazem, used to treat certain heart conditions: disturbances in heart rhythm and heart muscle weakness may occur.
• Centrally-acting antihypertensive agents (such as clonidine, alpha-methyldopa, moxonidine, reserpine): additional reduction in heart rate and cardiac output, as well as vasodilation, may occur. Sudden withdrawal may cause excessive increase in blood pressure. Centrally-acting antihypertensives should only be withdrawn after this medicine has been discontinued for several days.
• Lithium, used to treat depression: reduced elimination of lithium may lead to more severe damage to the nervous and cardiovascular systems.

Caution is advised when using the following medicines concomitantly with bisoprolol/hydrochlorothiazide:

• Calcium antagonists such as nifedipine and amlodipine (dihydropyridines), used to treat certain heart conditions: excessive drop in blood pressure may occur, especially at the beginning of treatment. In patients with latent heart failure, concomitant beta-blocker therapy may lead to manifestation of heart failure.

• ACE inhibitors such as captopril and enalapril, and angiotensin II antagonists, used to treat high blood pressure and other heart diseases: excessive drop in blood pressure and/or acute renal failure may occur at the beginning of treatment with ACE inhibitors.

• Medicines used to treat heart rhythm disorders (antiarrhythmics) such as disopyramide, quinidine, amiodarone, and sotalol: effects of bisoprolol/hydrochlorothiazide and antiarrhythmics on heart function may be additive. Serious, potentially fatal heart rhythm abnormalities (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 brain disorders): serious disturbances in heart rhythm may occur.

• Medicines called parasympathomimetics including tacrine, used in the treatment of Alzheimer's disease: risk of slow heart rate (bradycardia).

• Other beta-blockers, including those contained in eye drops for glaucoma treatment, used for heart or eye diseases, may have an additive effect.

• Medicines for diabetes such as insulin and sulfonylureas (e.g., glibenclamide, gliquidone, gliclazide, glipizide, glimepiride, or tolbutamide). Bisoprolol may increase the risk of severe hypoglycemia when used with these medicines. Warning signs of low blood sugar (hypoglycemia), especially rapid pulse (tachycardia), may be masked or less pronounced.

• Anesthetics: before undergoing general anesthesia, inform your anesthesiologist that you are taking bisoprolol/hydrochlorothiazide, as beta-blockers may interact with other medicines and affect how your body responds. If possible, continuing beta-blocker therapy before, during, and after surgery is recommended.

• Medicines such as digitalis, used to treat heart diseases such as congestive heart failure: any deficiency in potassium or magnesium may increase the likelihood of adverse reactions to digitalis.

• Prostaglandin synthesis inhibitors such as acetylsalicylic acid, used to relieve pain: the blood pressure-lowering effect of bisoprolol/hydrochlorothiazide may be reduced. Adverse effects of high doses of salicylates on the central nervous system may increase.

• Non-steroidal anti-inflammatory drugs such as ibuprofen, used to relieve pain: acute renal failure may occur in patients with reduced blood volume (hypovolemia).

• Ergot derivatives such as bromocriptine, used in diseases such as Parkinson's disease: existing circulatory disorders may worsen.

• Medicines called beta-sympathomimetics used to treat asthma or chronic obstructive lung diseases: the effects of both treatments may be weakened.

• Higher than usual doses of adrenaline may be needed to treat allergic reactions.

• Sympathomimetics that activate both beta- and alpha-adrenergic receptors (e.g., adrenaline, noradrenaline): combination with bisoprolol may cause increased blood pressure and worsen intermittent claudication.

• Tricyclic antidepressants such as amitriptyline, barbiturates such as phenobarbital, phenothiazines such as chlorpromazine, used to treat conditions such as depression, and other medicines that lower blood pressure: a greater blood pressure-lowering effect may occur.

• The effect of medicines that reduce uric acid may be weakened if taken simultaneously with bisoprolol/hydrochlorothiazide.

• Glucocorticoids such as hydrocortisone or dexamethasone (used to treat inflammation), ACTH (used to treat 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), used in cancer treatment: increased bone marrow toxicity may be expected.

• Cholestyramine, colestipol, used to treat high cholesterol: these medicines reduce the absorption of hydrochlorothiazide.

• Methyldopa, used to treat high blood pressure: in isolated cases, hemolysis (increased hemoglobin in blood due to red blood cell breakdown) has been reported due to antibody formation against hydrochlorothiazide.

• Mefloquine, used to treat malaria: increased risk of slow heart rate.

• Monoamine oxidase inhibitors (MAO) such as moclobemide or phenelzine, except MAO-B inhibitors like selegiline, used to treat conditions such as depression: excessive decreases or increases in blood pressure may occur.

Bisoprolol/Hydrochlorothiazide Teva with food and drinks

During treatment with Bisoprolol/Hydrochlorothiazide Teva, ensure you drink sufficient fluids and consume potassium-rich foods (e.g., bananas, vegetables, nuts) to compensate for potassium loss.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you are pregnant or think you might be. Your doctor will usually advise you to take another medicine instead of Bisoprolol/Hydrochlorothiazide Teva, as it 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

Inform your doctor if you are breastfeeding or plan to breastfeed. Bisoprolol/Hydrochlorothiazide Teva is not recommended for breastfeeding mothers.

Fertility

There are no data on the use of the combination product 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 affect your ability to drive or operate machinery, you should exercise caution, especially at the beginning of treatment, when changing medication, or after consuming alcohol. Dizziness may occasionally occur with this medicine. Individual reactions to the medicine may impair your ability to drive or use machines.

3. How to take Bisoprolol/Hydrochlorothiazide Teva

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

For oral use.

An individual dose adjustment with the substances separately (i.e., bisoprolol and hydrochlorothiazide) is recommended.

A direct switch from monotherapy to fixed-dose combination may be possible if your doctor considers it justified.

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

Patients with renal impairment, elderly patients

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

Method of administration

If possible, you should take this medicine in the morning with breakfast. Swallow the tablet whole, without chewing, with some liquid.

The tablet may be divided into equal doses.

Duration of administration

Your doctor will advise you on the duration of your treatment.

Use in children and adolescents

Bisoprolol/Hydrochlorothiazide Teva is not recommended in children, as there is no clinical experience in this population.

If you take more Bisoprolol/Hydrochlorothiazide Teva than you should

Seek medical attention. The healthcare professional may decide on the necessary measures depending on the extent of the overdose. In case of overdose, you must stop treatment with Bisoprolol/Hydrochlorothiazide Teva.

The most common signs of 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, somnolence, reduced blood volume (hypovolemia), and hypotension.

In case of overdose, treatment with this medicine must be stopped and you should consult your doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 915 620 420, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and the patient information 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 as instructed in this leaflet or as prescribed by your doctor.

If you stop taking Bisoprolol/Hydrochlorothiazide Teva

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

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

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.

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

• Difficulty breathing and swelling of the legs, which may be symptoms of worsening heart failure (may affect up to 1 in 100 people),
• Breathing problems and wheezing (bronchospasm), especially if you have asthma or chronic bronchial disease (may affect up to 1 in 100 people),
• Severe stomach and back pain with a general feeling of being unwell, which may be symptoms of a condition called pancreatitis (may affect up to 1 in 100 people),
• Flu-like symptoms and fever, which may be signs of reduced white blood cells (leucopenia) (may affect up to 1 in 1,000 people) or low number of granulocytes in the blood (agranulocytosis) (may affect up to 1 in 10,000 people),
• Easy bruising and/or nosebleeds, which may 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 may be caused by inflammation of the liver (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, light-sensitive rash (photosensitivity dermatitis), bleeding into the skin (purpura), hives; severe allergic reactions, which may 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 condition in which scaly patches develop on the skin) or skin rashes resembling psoriasis, worsening of existing psoriasis (may affect up to 1 in 10,000 people),
• Skin disorders with red scaly patches on the nose and cheeks (lupus erythematosus) (may affect up to 1 in 10,000 people),
• Acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion) (very rare, may affect up to 1 in 10,000 people).

Other possible adverse effects

Common (may affect up to 1 in 10 people)

• Some adverse effects may only be detected by blood tests, such as increased levels of blood fats (triglycerides, cholesterol), elevated blood glucose (hyperglycaemia), and increased serum uric acid levels (hyperuricaemia, which may be associated with gout),
• Glucose excretion in urine (glucosuria),
• Fluid and electrolyte imbalance disorders, especially reduced serum potassium levels (hypokalaemia, which may cause tiredness, exhaustion, muscle weakness, abnormal sensations in the limbs (paraesthesia), paralysis, apathy, weakening of smooth muscle leading to constipation, excessive gas accumulation in the gastrointestinal tract (flatulence), or disturbances in heart rhythm, intestinal obstruction, disturbances in consciousness, and coma),
• Reduced sodium levels (hyponatraemia, which may cause tiredness and confusion, muscle spasms, seizures or coma), reduced serum magnesium levels (hypomagnesaemia, which may be associated with muscle problems), reduced serum chloride levels (hypochloraemia),
• Increased serum calcium levels (hypercalcaemia, causing abdominal pain, nausea and vomiting, constipation, loss of appetite, excessive thirst, excessive urination, fatigue, weakness, and weight loss),
• Increase in acid levels in the blood (metabolic acidosis, which may be associated with lethargy, nausea, vomiting, rapid breathing),
• Fatigue*,
• Dizziness*,
• Headache*,
• Feeling of coldness or numbness in the limbs,
• Nausea, vomiting, diarrhoea, constipation.

Uncommon (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 may be associated with postural changes and may be characterized by feelings of faintness and weakness when standing up after sitting (orthostatic hypotension),
• Loss of appetite,
• Abdominal pain,
• Some adverse effects may be detected by blood tests: increase in 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 production (take this into account if you wear contact lenses),
• Visual disturbances,
• Hearing disorders,
• Circulatory collapse (syncope),
• Allergic rhinitis (runny nose),
• Some adverse effects may only be detected by blood tests: increase in certain liver enzymes in the blood (AST, ALAT),
• Erectile dysfunction.

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

• Some adverse effects may only be detected by blood tests, such as metabolic alkalosis,
• Conjunctivitis (inflammation of the lining around the eye),
• Hair loss.

Frequency not known (cannot be estimated from available data)

• Skin and lip cancer (non-melanoma skin cancer),
• Loss of vision or eye pain due to increased 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 occur especially at the beginning of treatment. They are usually mild and normally disappear within one or two weeks.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bisoprolol/Hydrochlorothiazide Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister after "EXP". The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bisoprolol/Hydrochlorothiazide Teva

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

Appearance of Bisoprolol/Hydrochlorothiazide Teva and contents of the pack

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.

C/ 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

The Netherlands

or

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80

31-546 Kraków

Poland

This medicinal product is authorised in the Member States of the European Economic Area (EEA) under the following names:

BE: Co-Bisoprolol TEVA 10 mg / 25 mg filmomhulde tabletten

DE: Bisoprolol-TEVA® comp. 10 mg / 25 mg Filmtabletten

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

Date of the most recent revision of this leaflet: January 2026

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

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. 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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