HYDROCHLOROTHIAZIDE AUROVITAS 25 mg TABLETS

Introduction

Package Leaflet: Information for the User

Hydrochlorothiazide Aurovitas 25 mg Tablets EFG

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

1. What is Hydrochlorothiazide Aurovitas and what is it used for
2. What you need to know before you take Hydrochlorothiazide Aurovitas
3. How to take Hydrochlorothiazide Aurovitas
4. Possible side effects
5. Storage of Hydrochlorothiazide Aurovitas
6. Contents of the pack and other information

1. What is Hydrochlorothiazide Aurovitas and what is it used for

Hydrochlorothiazide Aurovitas belongs to a group of medicines called “diuretics”. Diuretics increase the amount of urine that is passed.

Hydrochlorothiazide is used in adults to treat:

• Fluid retention in the tissues that causes swelling (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 medicine.

2. What you need to know before you take Hydrochlorothiazide Aurovitas

Do not take Hydrochlorothiazide Aurovitas:

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Hydrochlorothiazide Aurovitas:

• If you have had respiratory or lung 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 hydrochlorothiazide, seek medical attention immediately.

• If you have severe kidney or liver disease.
• If you have narrowing of the renal artery (narrowing of the blood vessels that supply both kidneys or just one).
• If you have diabetes (high blood sugar levels).
• If your cholesterol or triglyceride levels are high.
• If you have had a disease called “lupus erythematosus” (also called “lupus” or “LES”).
• If you have low potassium levels in your blood (with or without symptoms such as muscle weakness, muscle spasms, or irregular heartbeats).
• If you have low sodium levels in your blood (with or without symptoms such as fatigue, confusion, muscle spasms, or cramps).
• If your calcium levels in the blood have increased (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness, or spasms).
• If you suffer from gout attacks (deposits of uric acid crystals in the joints).
• If you experience a decrease in vision or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within a few hours to a week after taking this medicine. In the absence of treatment, this can lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamide, you may be at greater risk of suffering from it.
• If you have an allergy or asthma.
• If you have skin reactions, such as a rash after sun exposure.
• If you are taking any other medicine.

• If you are pregnant or planning to become pregnant.
• 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 hydrochlorothiazide.

In chronic diuretic users, a pseudo-Bartter syndrome may appear along with fluid retention in the body's tissues (edema).

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

Exposure to sunlight or UV cabins

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

Blood tests

It is possible that your doctor will ask you to have blood tests done regularly during treatment to monitor your kidney function and especially your sodium, potassium, calcium, sugar (glucose), and uric acid levels in your blood.

Elderly patients (65 years and older)

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

Other medicines and Hydrochlorothiazide Aurovitas

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

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

• Desmopressin (for diabetes or urinary problems).
• Chelating resins (substances used mainly to treat high lipid levels in the blood).
• Domperidone (to stop nausea and vomiting).
• Medicines to treat malaria (e.g., halofantrine, lumefantrine).
• Medicines 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).
• Medicines to treat prostate disorders (alfuzosin, doxazosin, prazosin, silodosin, tamsulosin, terazosin).
• Medicines to treat erectile dysfunction.
• Medicines used in Parkinson's disease (dopamine agonists, levodopa).
• Baclofen (to treat muscle stiffness that occurs in diseases such as multiple sclerosis).
• Calcium tablets or other calcium supplements.
• Methadone (to treat addiction to certain active substances).
• Medicines to treat certain types of cancer (vandetanib, toremifene).
• Vincamine (used to treat neurological disorders related to aging).
• Cyclosporin (used after organ transplantation, to treat autoimmune diseases or severe rheumatic or dermatological diseases).

Hydrochlorothiazide Aurovitas with food and drinks

Do not consume alcohol while taking this medicine because it can cause you to have 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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

This medicine passes into the placenta and its use after the third month of pregnancy may cause serious harm to your baby.

Breastfeeding

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

Driving and using machines

Hydrochlorothiazide tablets have a mild or moderate influence on the ability to drive and use machines.

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

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

Doping test

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

Hydrochlorothiazide Aurovitas contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Hydrochlorothiazide Aurovitas

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Edema:

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

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

High blood pressure (hypertension):

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

Elderly patients:

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

Use in children and adolescents

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

Method of administration

For oral use.

Swallow the tablets with a sufficient amount of liquid.

This medicine can be taken with or without food.

The tablets can be divided into equal doses.

Frequency of administration

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

Duration of treatment

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

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

If you take more Hydrochlorothiazide Aurovitas than you should

Contact your doctor or go immediately to the hospital emergency department if you experience nausea, drowsiness, muscle contractions, irregular heartbeats, low blood pressure, confusion, or urinary problems.

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

If you forget to take Hydrochlorothiazide Aurovitas

If you forget to take a dose, you should take it as soon as you remember. Do not take a double dose to make up for forgotten doses, continue treatment as prescribed.

If you stop taking Hydrochlorothiazide Aurovitas

Do not stop treatment with hydrochlorothiazide unless your doctor tells you to. If you stop treatment, your blood pressure will not be controlled (see also “Duration of treatment”).

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Effects that require stopping treatment

You must stop treatment and consult a doctor or the hospital emergency department if you have a reaction to sunlight (skin reaction).

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

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

Common (may affect up to 1 in 10 people)

• Itchy rash (urticaria) and other skin rashes.
• Lack 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).
• Decrease in magnesium levels in the blood (hypomagnesemia).
• Decrease in sodium levels in the blood (hyponatremia).
• Increased 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 yellowing of the eyes and skin.
• Irregular heartbeat.
• Headache.
• Rotating dizziness.
• Sleep disorders.
• Feeling sad (depression).
• Numbness or tingling of the hands or feet (paresthesia).
• Vision problems.
• Increased blood sugar levels.
• Sugar in the urine.
• Increased calcium levels in the blood (hypercalcemia).
• Low platelet count in the blood, sometimes with bleeding or bruising on the skin (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 the blood vessels with symptoms such as rash, red purplish marks on the skin, fever (necrotizing vasculitis).
• Severe skin reaction that causes rash, redness of the skin, blisters on the lips, eyes, or mouth, skin peeling, fever (toxic epidermal necrolysis).
• Allergic reaction (hypersensitivity reaction).

• Acute difficulty breathing (signs include severe difficulty breathing, 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 number of white blood cells and platelets.
• Destruction of red blood cells that causes paleness, tiredness, shortness of breath, dark urine (hemolytic anemia).
• Absence or low level of white blood cells that can cause fever, sore throat, or mouth ulcers, more frequent infections (leukopenia or possible signs of agranulocytosis).
• Disruption of acid-base balance that causes confusion, fatigue, muscle contractions, and spasms, rapid breathing (hypochloremic alkalosis).

Frequency not known (cannot be estimated from the 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, redness of the skin, blisters on the lips, eyes, or mouth, skin peeling, fever (erythema multiforme).
• Fever.
• Muscle spasms.
• Weakness (asthenia).
• Sudden decrease in distant vision (acute myopia), decreased vision, or eye pain due to high eye pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
• Skin and lip cancer (non-melanoma skin cancer).

Reporting of side effects

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

5. Storage of Hidroclorotiazida Aurovitas

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

Do not use this medicine after the expiry date which is stated on the carton or blister after CAD. The expiry date is the last day of the month indicated.

This medicine does not require any special temperature for storage.

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

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

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

6. Package Contents and Additional Information

Composition ofHidroclorotiazida Aurovitas

• The active ingredient is hydrochlorothiazide. Each tablet contains 25 mg of hydrochlorothiazide.
• The other ingredients are:

Tablet core:lactose monohydrate, calcium hydrogen phosphate dihydrate, pregelatinized corn starch, corn starch, anhydrous colloidal silica, and magnesium stearate.

Appearance of the Product and Package Contents

Uncoated tablets, white to off-white in color, round in shape, with flat faces and a beveled edge, marked with "HC 25" on one face and a score line 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, and 100 tablets.

PEAD bottle (for all doses):500 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Arrow Generiques – Lyon

26 avenue Tony Garnier,

Lyon, 69007

France

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany HCT PUREN 25 mg Tabletten

Spain Hidroclorotiazida Aurovitas 25 mg tablets EFG

France Hydrochlorothiazide Arrow 25 mg, scored tablet

Italy Idroclorotiazide Aurobindo

Netherlands Hydrochloorthiazide Aurobindo 25 mg, tablets

Poland Hydrochlorothiazide Aurovitas

Portugal Hidroclorotiazida Generis

Czech Republic Hydrochlorothiazide Aurovitas

Date of the last revision of this leaflet:March 2022

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