Prospect: Patient Information

Candesartán/Hidroclorotiazida ratiomed 8 mg/12,5 mg tablets EFG

Candesartán cilexetilo/ Hidroclorotiazida

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

1.What is Candesartán/ Hidroclorotiazida ratiomed and for what it is used

2.What you need to know before starting to take Candesartán/ Hidroclorotiazida ratiomed

3.How to take Candesartán/ Hidroclorotiazida ratiomed

4.Possible adverse effects

5.Storage of Candesartán /Hidroclorotiazida ratiomed

6.Contents of the package and additional information

Your medication is called Candesartán/Hidroclorotiazida ratiomed. It is used for the treatment of high blood pressure (hypertension) in adult patients. It contains two active ingredients: candesartán cilexetilo and hidroclorotiazida. Both work together to lower blood pressure.

• Candesartán cilexetilo belongs to a group of medications called angiotensin II receptor antagonists. It causes your blood vessels to relax and dilate. This facilitates a decrease in blood pressure.
• Hidroclorotiazida belongs to a group of medications called diuretics. It promotes the elimination of water and salt, such as sodium, in your urine. This facilitates a decrease in blood pressure.

Your doctor may prescribe Candesartán/Hidroclorotiazida ratiomed if your blood pressure has not been adequately controlled with candesartán cilexetilo or hidroclorotiazida alone.

Do not take Candesartán/Hidroclorotiazida ratiomed

• if you are allergic to candesartán cilexetilo or to hidroclorotiazida or to any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to sulfonamides.If you are unsure whether you are in this situation, consult your doctor,
• if you are more than 3 months pregnant (it is best to avoid Candesartán/Hidroclorotiazida ratiomed during the first months of pregnancy - see section 2: Pregnancy and breastfeeding),
• if you have severe kidney disease,
• if you have severe liver disease or biliary obstruction (a problem with the bile flowing from the gallbladder),
• if you have persistent low levels of potassium in the blood,
• if you have persistent high levels of calcium in the blood,
• if you have ever had gout.
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure lowering medicine that contains aliskirén.

If you are unsure whether you are in any of these situations, consult your doctor or pharmacist before taking Candesartán/Hidroclorotiazida ratiomed.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Candesartán/Hidroclorotiazida ratiomed

• if you are diabetic,
• if you have heart, liver or kidney problems,
• if you have recently had a kidney transplant,
• if you have been vomiting, have had it frequently recently or have diarrhoea,
• if you have a condition called Conn's syndrome (also known as primary aldosteronism),
• if you have ever had a condition called systemic lupus erythematosus (SLE),
• if you have low blood pressure,
• if you have ever had a stroke,
• if you have had an allergy or asthma,
• 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 haemorrhage) or an increase in eye pressure and can occur within a few hours to weeks after taking Candesartán/Hidroclorotiazida ratiomed.If left untreated, this can lead to permanent loss of vision. If you have previously had an allergy to penicillin or sulfonamide, you may be at a higher risk of developing it,
• you must inform your doctor if you think you are (or could be) pregnant. Candesartán/Hidroclorotiazida ratiomed is not recommended for use at the start of pregnancy andshould not be takenif you are more than 3 months pregnant, as it can cause serious harm to your baby when used from that point onwards (see section 2: Pregnancy and breastfeeding),

• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,
  • aliskirén,

• if you are taking an ACE inhibitor together with a medicine belonging to the class of drugs called mineralocorticoid receptor antagonists (MRAs). These medicines are used for the treatment of heart failure (see “Taking Candesartán/Hidroclorotiazida ratiomed with other medicines”),
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Candesartán/Hidroclorotiazida ratiomed.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after takingCandesartán/Hidroclorotiazida ratiomed, go to your doctor immediately.

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

See also the information under the heading “Do not take Candesartán/Hidroclorotiazida ratiomed”.

Consult your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Candesartán/Hidroclorotiazida ratiomed. Your doctor will decide whether to continue treatment. Do not stop taking this medicine on your own.

If you are to undergo surgery, inform your doctor or dentist that you are takingCandesartán/Hidroclorotiazida ratiomed. This is becauseCandesartán/Hidroclorotiazida ratiomed,in combination with some anaesthetics, can cause a drop in blood pressure.

Candesartán/Hidroclorotiazida ratiomed may increase your skin's sensitivity to the sun.

Children and adolescents

There is no experience with the use ofCandesartán/Hidroclorotiazida ratiomed in children (under 18 years). Therefore Candesartán/Hidroclorotiazida ratiomed should not be administered to children.

Use in athletes

This medicine contains hidroclorotiazida which may produce a positive result in doping control tests.

Taking Candesartán/Hidroclorotiazida ratiomed with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken or may need to take any other medicine.Candesartán/Hidroclorotiazida ratiomed may affect the way some medicines work and some medicines may influence the effect of Candesartán/Hidroclorotiazida ratiomed. If you are using certain medicines, your doctor may need to perform blood tests at regular intervals.

Especially, inform your doctor if you are using any of the following medicines:

• Other medicines to lower your blood pressure, including beta-blockers and diazoxide.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen or diclofenac, celecoxib or etoricoxib (pain-relieving and anti-inflammatory medicines).
• Aspirin (if you take more than3 gper day) (pain-relieving and anti-inflammatory medicines).
• Potassium supplements or salt substitutes containing potassium (medicines to increase potassium levels in the blood).
• Calcium supplements or vitamin D.
• Medicines to reduce cholesterol, such as colestipol or colestiramine.
• Medicines for diabetes (tablets or insulin).
• Medicines to control heart rhythm (antiarrhythmic agents) such as digoxin and beta-blockers.
• Medicines that may be affected by potassium levels in the blood such as some antipsychotic medicines.
• Heparin (a medicine to increase blood fluidity).
• Diuretics (medicines to promote urine production).
• Laxatives.
• Penicillin or trimethoprim/sulfamethoxazole (antibiotics).
• Amphotericin (for the treatment of fungal infections).
• Lithium (a medicine for mental health problems).
• Glucocorticoids such as prednisolone.
• Pituitary hormone (ACTH).
• Cancer medicines.
• Amantadine (for the treatment of Parkinson's disease or severe viral infections).
• Barbiturates (a type of sedative also used to treat epilepsy).
• Carbenoxolone (for the treatment of oesophageal disease or mouth ulcers).
• Anticholinergic agents such as atropine and biperiden.
• Ciclosporin, a medicine used for organ transplants to prevent organ rejection.
• Other medicines that may increase the antihypertensive effect such as baclofen (a medicine for muscle spasms), amifostine (used in cancer treatment) and some antipsychotic medicines.

Your doctor may need to modify your dose and/or take other precautions:

• if you are taking an ACE inhibitor or aliskirén (see also the information for the headings “Do not take Candesartán/Hidroclorotiazida ratiomed” and “Warnings and precautions”).

Taking Candesartán/Hidroclorotiazida ratiomed with food, drinks and alcohol

You can take Candesartán/Hidroclorotiazida ratiomed with or without food.

• When you are prescribed Candesartán/Hidroclorotiazida ratiomed, consult your doctor before taking alcohol. Alcohol may make you feel dizzy or lightheaded.

Pregnancy and breastfeeding

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

Pregnancy

You must inform your doctor if you think you are (or could be) pregnant.Your doctor will usually recommend that you stop taking Candesartán/Hidroclorotiazida ratiomed before becoming pregnant or as soon as you know you are pregnant, and will recommend taking another medicine instead ofCandesartán/Hidroclorotiazida ratiomed. Candesartán/Hidroclorotiazida ratiomed is not recommended for use at the start of pregnancy,andshould not be takenif you are more than 3 months pregnant,as it can cause serious harm to your baby if used from that point onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start. Candesartán/Hidroclorotiazida ratiomed is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines. Some patients may feel tired or dizzy when takingCandesartán/Hidroclorotiazida ratiomed. If this happens to you, do not drive or operate tools or machines.

Candesartán/Hidroclorotiazida ratiomed contains lactose

Candesartán/Hidroclorotiazida ratiomed containslactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

Candesartán/Hidroclorotiazida Teva contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.This medication should be taken exactly as directed by your doctor.

The recommended dose is one tablet once a day. Swallow the tablet with a glass of water.

Try to take the tablet at the same time every day. This will help you remember to take it.

The groove is only for splitting and facilitating swallowing, but not for dividing into equal doses.

If you take more Candesartán/ Hidroclorotiazida ratiomed than you should

If you take more Candesartán/ Hidroclorotiazida ratiomed than prescribed by your doctor, consult your doctor or pharmacist immediately for advice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Candesartán/ Hidroclorotiazida ratiomed

Do not take a double dose to compensate for the missed dose. Simply take the next dose as usual.

If you interrupt treatment with Candesartán/ Hidroclorotiazida ratiomed
High blood pressure treatment is usually for life, and therefore, do not stop taking this medication without consulting your doctor.

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

Like all medications,this medicationmay cause side effects, although not everyone will experience them.

It is essential that you know which side effects could occur. Some side effects ofCandesartán/ Hidroclorotiazida ratiomedare due to candesartán cilexetilo and others are due to hydrochlorothiazide.

Stop taking Candesartán /Hidroclorotiazida ratiomed and see your doctor immediately if you experience any of the following severe reactions:

Rare (may affect up to 1 in 100 people):

• Severe skin itching (with skin rash).

Uncommon (may affect up to 1 in 1,000 people):

• Difficulty breathing, with or without swelling of the face, lips, tongue, and/or throat,
• Jaundice (yellowing of the skin or the white of the eyes)

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

• Swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing,
• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Candesartán/ Hidroclorotiazida ratiomed may cause a decrease in white blood cells. Your resistance to infections may decrease, and you may feel tired, have an infection, or fever. If this occurs, inform your doctor. It is possible that your doctor will perform blood tests at regular intervals to check that Candesartán/ Hidroclorotiazida ratiomed is not affecting your blood (agranulocytosis).

Other possible side effects include:

Common (may affect up to 1 in 10 people)

• Changes in blood test results:
• • A reduction in sodium levels in the blood. If severe, you may feel weak, lack energy, or experience muscle cramps.
  • An increase or decrease in potassium levels in the blood, especially if you have kidney problems or heart failure. If severe, you may feel tired, weak, experience irregular heartbeats, or tingling.
  • An increase in cholesterol, glucose, or uric acid levels in the blood.

• Presence of glucose in urine.
• Sensation of dizziness or weakness.
• Headache
• Respiratory infection

Rare (may affect up to 1 in 100 people)

• Low blood pressure. This may cause dizziness or fainting.
• Loss of appetite, diarrhea, constipation, stomach irritation.
• Skin rash, hives, skin reaction caused by sensitivity to sunlight.

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

• Effects on kidney function, especially if you have kidney problems or heart failure.
• Difficulty sleeping, depression, or anxiety.
• Tickling or pinching sensations in arms and legs.
• Blurred vision for a short period.
• Abnormal heartbeats.
• Difficulty breathing (including pulmonary inflammation and fluid in the lungs).
• Fever.
• Pancreatitis. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels that produce red or purple spots on the skin.
• Decrease in red blood cells, white blood cells, or platelets. You may feel tired, have an infection, fever, or easily bruise.
• Severe skin reaction that develops rapidly, causing blisters and skin peeling, and possibly mouth ulcers.
• Worsening of pre-existing lupus erythematosus or development of rare skin reactions.

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

• Back pain, joint and muscle pain.
• Changes in liver function, including hepatitis. You may feel tired, have yellowing of the skin and the white of the eyes, and experience flu-like symptoms.
• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
• Cough.
• Nausea.

Frequency unknown (cannot be estimated from available data)

• Sudden myopia.
• Loss of vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage or acute angle-closure glaucoma).
• SLE and cutaneous lupus (allergic condition that causes fever, joint pain, skin rash that may include redness, blisters, exfoliation, and nodules).
• Skin and lip cancer (non-melanoma skin cancer).

Reporting side effects

If you experience any type of side effects,consult your doctor or pharmacist,eveniftheydo not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not usethis medicationafter the expiration date that appears on the packaging or blister. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Candesartán/ Hidroclorotiazida ratiomed

- The active principles are candesartán cilexetilo and hidroclorotiazida. Each tablet contains 8 mg of candesartán cilexetilo and 12.5 mg of hidroclorotiazida.

- The other components are: pregelatinized cornstarch, povidone K-30, calcium carmelose, poloxamer 188, microcrystalline cellulose, lactose monohydrate (dried by spray drying), magnesium stearate.

Appearance of the product and contents of the package

Candesartán /Hidroclorotiazida ratiomed 8 mg/12.5 mg are white or almost white tablets, in capsule shape, biconvex, one face of the tablets is scored and engraved with “C” on the left side of the score and with “8” on the right side of the score. The other face of the tablet is scored.

Candesartán/ Hidroclorotiazida ratiomed 8 mg/12.5 mgis available in package sizes of 7, 10, 14, 15, 28, 30, 50, 56, 90, 98, 100, 300 tablets; 28 x 1, 50 x 1, 56 x 1, and 98 x 1 single-dose blisters (hospital pack).

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Teva Pharma, S.L.U.

c/ Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible for manufacturing:

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 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

Or

PLIVA Croatia Ltd.

Prilaz baruna Filipovica 25, 10000 Zagreb

Croatia

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Candesartan comp.AbZ

Spain:Candesartán/ Hidroclorotiazida ratiomed 8 mg/12.5 mg tablets EFG

Last review date of this leaflet: January 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/