Package Insert: Information for the User

Hidroclorotiazida Aurovitas 25 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others 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 are not listed in this package insert. See section 4.

Hidroclorotiazida Aurovitas belongs to a group of medications called “diuretics”. Diuretics increase the volume of liquid that is eliminated in the urine.

Hidroclorotiazida is used in adults to treat:

• Fluid retention in tissues that cause inflammation (edema) as a result of heart, liver, or kidney disease.
• High blood pressure (hypertension). In this case, it may be prescribed alone or in combination with another medication.

Do not take Hidroclorotiazida Aurovitas:

• If you are allergic to hydrochlorothiazide or any of the other ingredients of this medication (listed in section 6).
• If you are unable to urinate (have anuria).
• If you have severely impaired renal function.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Hidroclorotiazida Aurovitas:

• 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 severe shortness of breath or difficulty breathing after taking hydrochlorothiazide, seek medical attention immediately.

• If you have severe renal or hepatic disease.
• If you have renal artery stenosis (narrowing of the blood vessels that supply both kidneys or only one).
• If you have diabetes (high blood sugar levels).
• If you have high levels of cholesterol or triglycerides.
• If you have had a disease called "lupus erythematosus" (also called "lupus" or "LES").
• If you have low levels of potassium in your blood (with or without symptoms such as muscle weakness, muscle spasms, or irregular heartbeats).
• If you have low levels of sodium in your blood (with or without symptoms such as fatigue, confusion, spasms, or muscle cramps).
• If your blood calcium levels have increased (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness, or spasms).
• If you experience gout attacks (deposition of uric acid crystals in the joints).
• If you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within a few hours to a week after taking this medication. Without treatment, this can lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamide, you may be at a higher risk.
• If you have allergies or asthma.
• If you have skin reactions, such as skin rash after exposure to the sun.
• If you are taking any other medication.

• If you are pregnant or intend to become pregnant.
• If you have had skin cancer or if a skin lesion appears unexpectedly during treatment. The treatment with hydrochlorothiazide, 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 hydrochlorothiazide.

In chronic consumers of diuretics, a pseudo-Bartter syndrome may appear along with water retention in the body tissues (edema).

During treatment with this medication, you should drink enough liquid. Due to the increased loss of potassium, you should follow a diet rich in potassium (e.g., bananas, vegetables, nuts).

Exposure to sunlight or UV cabins

If you have had sensitivity to sunlight due to this medication and your doctor decided to continue treatment, you must protect your skin from the sun and should not use UV tanning cabins (see also section 4 for what to do if these side effects occur).

Blood tests

Your doctor may ask you to have regular blood tests during treatment to monitor your renal function and especially your levels of sodium, potassium, calcium, sugar (glucose), and uric acid in your blood.

Patients over 65 years old

In the treatment of elderly patients, attention should be paid to possible restrictions on renal function (see section 3).

Other medications and Hidroclorotiazida Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Your doctor may need to change the dose and/or take other precautions if you are taking other medications, especially if you are taking any of the following:

• Lithium (a medication used for mental health problems), as its combination with hydrochlorothiazide may cause lithium overdose.
• Medications to lower blood pressure or treat heart disease (e.g., diuretics, ACE inhibitors such as ramipril, angiotensin II antagonists such as valsartan, digoxin, nitrates, and similar).
• Medications to treat mental health problems such as depression, anxiety, schizophrenia (e.g., antidepressants, anxiolytics, antipsychotics, neuroleptics).
• Medications to treat arrhythmias (e.g., hydroquinidine, disopyramide, amiodarone, dronedarone, sotalol, digoxin).
• Medications used for pain or inflammation, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen) and aspirin.
• Carbamazepine or oxcarbazepine (for epilepsy treatment).
• Laxatives and other laxatives.
• Corticosteroids.

• Desmopressin (for diabetes or urinary problems).
• Resin chelators (substances used mainly to treat high levels of lipids in the blood).
• Domperidone (to interrupt nausea and vomiting).
• Medications to treat malaria (e.g., halofantrine, lumefantrine).
• Medications to treat allergic reactions (e.g., mizolastine, mequitazine).
• Antibiotics to treat infections (e.g., amphotericin B, erythromycin, levofloxacin, moxifloxacin, spiramycin).
• Iodinated contrast agents (used in imaging studies).
• Medications to treat prostate problems (alfuzosin, doxazosin, prazosin, silodosin, tamsulosin, terazosin).
• Medications to treat erectile dysfunction.
• Medications used in Parkinson's disease (dopamine agonists, levodopa).
• Baclofen (to treat muscle rigidity that occurs in diseases such as multiple sclerosis).
• Calcium tablets or other calcium supplements.
• Methadone (to treat addiction to certain active principles).
• Medications to treat certain types of cancer (vandetanib, toremifene).
• Vincamine (used to treat neurological disorders related to aging).
• Ciclosporin (used after organ transplantation, to treat autoimmune diseases or severe rheumatic or dermatological diseases).

Hidroclorotiazida Aurovitas with food and drinks

Do not consume alcohol while taking the medication because it may cause orthostatic hypotension (a sudden drop in blood pressure that causes dizziness due to a change in position, e.g., standing up).

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Generally, your doctor will recommend that you take another medication instead of hydrochlorothiazide because it is not recommended during pregnancy, except in rare cases where no other treatment can be used.

This medication crosses the placenta and its use after the third month of pregnancy may cause severe damage to your baby.

Breastfeeding

Hydrochlorothiazide passes into breast milk. Do not take this medication while breastfeeding unless your doctor tells you to.

Driving and operating machines

The hydrochlorothiazide tablets have a mild or moderate effect on your ability to drive and operate machines.

Even when used as directed, this medication may affect your reflexes. Therefore, your ability to drive, operate machinery, or work in places without a solid support may be affected.

This is especially evident at the beginning of treatment, when the dose is increased, the medication is changed, or when it is taken in combination with alcohol.

Drug test

Hydrochlorothiazide may produce a positive analytical result in a drug test.

Hidroclorotiazida Aurovitas contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

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

Hidroclorotiazida Aurovitas tablets are available in 3 doses: 12.5 mg, 25 mg, and 50 mg tablets.

Edemas:

The initial recommended dose is 50 mg to 100 mg of hidroclorotiazida per day.

The maintenance dose is usually 25 mg to 50 mg of hidroclorotiazida per day.

Hypertension (high blood pressure):

The currently recommended doses in arterial hypertension are 12.5 or 25 mg/day.

Older patients:

In the treatment of older patients (65 years or more), attention should be paid to possible restrictions on renal function.

Use in children and adolescents

There is no experience in children and adolescents. Therefore, hidroclorotiazida should not be administered to children and adolescents.

Administration form

For oral use.

Swallow the tablets with a sufficient amount of liquid.

This medication can be taken with or without food.

The tablets can be divided into equal doses.

Administration frequency

This medication has a diuretic effect (i.e., you will urinate more often). Given this, it is best not to take the last dose at the end of the day to avoid waking up at night. If you take your tablets as a single dose, take them in the morning.

Treatment duration

Your doctor will tell you how long you should take this medication.

Your doctor will perform regular checks to ensure that the treatment has the expected effects. If you have any questions about the treatment duration, consult your doctor or pharmacist.

If you take more Hidroclorotiazida Aurovitas than you should

Contact your doctor or go immediately to the hospital's emergency service if you experience nausea, drowsiness, muscle contractions, arrhythmias (irregular heartbeat), low blood pressure (identifiable by dizziness), confusion, or urinary problems.

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 forget to take Hidroclorotiazida Aurovitas

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to compensate for the missed doses, continue treatment as prescribed.

If you interrupt treatment with Hidroclorotiazida Aurovitas

Do not interrupt treatment with hidroclorotiazida unless your doctor tells you to. If you interrupt treatment, your blood pressure will not be controlled (see also "Treatment duration").

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Effects that require discontinuation of treatment

You should discontinue treatment and consult a doctor or the hospital's emergency service if you have a sun reaction (skin reaction).

Very common (may affect more than 1 in 10 people)

• Increased levels of lipids in the blood (hyperlipidemia).
• Decreased levels of potassium (hypokalemia).

Common (may affect up to 1 in 10 people)

• Itchy skin rash (urticaria) and other skin rashes.
• Loss of appetite, nausea, vomiting, diarrhea.
• Drop in blood pressure when changing from a lying down to a standing position.
• Inability to achieve or maintain an erection (impotence).
• Decreased levels of magnesium in the blood (hypomagnesemia).
• Decreased levels of sodium in the blood (hyponatremia).
• Increased levels of uric acid in the blood (hyperuricemia).

Uncommon (may affect up to 1 in 100 people)

• Acute kidney failure (severely decreased urine flow).

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

• Worsening of diabetes.
• Increased sensitivity to sunlight.
• Abdominal discomfort, constipation.
• Liver disorder that may be accompanied by yellow discoloration of the eyes and skin.
• Irregular heartbeat.
• Headache.
• Rotatory vertigo.
• Sleep disorders.
• Feeling sad (depression).
• Tickling or numbness of the hands or feet (paresthesia).
• Visual problems.
• Increased levels of sugar in the blood.
• Sugar in the urine.
• Increased levels of calcium in the blood (hypercalcemia).
• Low platelet count in the blood, sometimes with bleeding or skin hematomas (thrombocytopenia).

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

• Rash on the face, joint pain, muscle problems, fever (lupus erythematosus).
• Inflammation of blood vessels with symptoms such as rash, red purpura marks on the skin, fever (necrotizing vasculitis).
• Severe skin reaction that causes rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (toxic epidermal necrolysis).
• Allergic reaction (hypersensitivity reaction).

• Acute respiratory difficulty (symptoms include severe respiratory difficulty, fever, weakness, and confusion).

• Severe abdominal pain (pancreatitis).

• Depression of the bone marrow that results in a reduction in the number of red blood cells and/or an abnormally low level of white blood cells and platelets.
• Destruction of red blood cells that causes paleness, fatigue, shortness of breath, dark urine (hemolytic anemia).
• Absence or low level of white blood cells that may cause fever, sore throat, or mouth sores, more frequent infections (leukopenia or possible signs of agranulocytosis).
• Alteration of acid-base balance that causes confusion, fatigue, muscle contractions, and spasms, rapid breathing (hypochloremic alkalosis).

Unknown frequency (cannot be estimated from available data)

• Inadequate production of different blood cells by the bone marrow (myelosuppression).
• Significant decrease in urine production (possible signs of kidney problems).
• Severe skin disease that causes rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (erythema multiforme).
• Fever.
• Muscle spasms.
• Weakness (asthenia).
• Sudden decrease in distant vision (acute myopia), decrease in vision or eye pain due to high eye pressure (possible signs of accumulation of fluid in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma).
• Skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging or blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Keep the blister pack in the outer packaging to protect it from light.

Keep the bottle in the original packaging to protect it from light.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofHidroclorotiazida Aurovitas

• The active ingredient is hidroclorotiazida. Each tablet contains 25 mg of hidroclorotiazida.
• The other components are:

Tablet core:lactose monohydrate, calcium dihydrogen phosphate, pregelatinized cornstarch, cornstarch, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the package

Uncoated tablets, white to off-white in color, round in shape, flat faces, and beveled edges, marked with “HC 25” on one face and a notch on the other face. The tablet can be divided into equal doses.

Hidroclorotiazida Aurovitas tablets are available in blister packs and PEAD bottles.

Blister pack:20, 30, 40, 50, 60, 90 & 100 tablets.

PEAD bottle (for all doses):500 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Arrow Generiques – Lyon

26 avenue Tony Garnier,

Lyon, 69007

France

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

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

GermanyHCT PUREN25 mgTabletten

SpainHidroclorotiazida Aurovitas 25 mg comprimidos EFG

FranceHydrochlorothiazide Arrow 25 mg, comprimé sécable

ItalyIdroclorotiazide Aurobindo

NetherlandsHydrochloorthiazide Aurobindo25 mg,tabletten

PolandHydrochlorothiazide Aurovitas

PortugalHidroclorotiazida Generis

Czech RepublicHydrochlorothiazide Aurovitas

Last review date of this leaflet:March 2022

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