Hydrochlorothiazide Aurovitas 50 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Hydrochlorothiazide Aurovitas 50 mg tablets

Read the entire leaflet carefully before you start taking this medicine, because 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 you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Hidroclorotiazida Aurovitas belongs to a group of medicines called "diuretics". Diuretics increase the volume of fluid eliminated in the urine.

Hidroclorotiazida is used in adults to treat:

• Fluid retention in the tissues causing swelling (edema) resulting from 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 taking Hidroclorotiazida Aurovitas

Do not take Hidroclorotiazida 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

Talk to your doctor or pharmacist before taking Hidroclorotiazida Aurovitas:

• If you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop 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 renal artery stenosis (narrowing of the blood vessels supplying one or both kidneys).

• If you have diabetes (high blood sugar levels).

• If your cholesterol or triglyceride levels are high.

• If you have had a disease called "systemic lupus erythematosus" (also called "lupus" or "SLE").

• If you have low levels of potassium in your blood (with or without symptoms such as muscle weakness, muscle cramps, or irregular heartbeat).

• If you have low levels of sodium in your blood (with or without symptoms such as fatigue, confusion, muscle spasms, or cramps).

• If your blood calcium levels are elevated (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness, or spasms).

• If you suffer from gout attacks (deposition of uric acid crystals in the joints).

• If you experience vision changes or eye pain, which could be signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, occurring within hours to a week after taking this medicine. Without treatment, this may lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk.

• If you have allergies or asthma.

• If you develop skin reactions, such as a rash after sun exposure.

• If you are taking any other medication.

• If you are pregnant or planning to become pregnant.

• 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 cancer and lip cancer. Protect your skin from sun and UV exposure while taking hydrochlorothiazide.

Chronic users of diuretics may develop a pseudo-Bartter syndrome along with fluid retention in body tissues (edema).

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

Exposure to sunlight or UV cabins

If you have experienced sensitivity to sunlight due to this medicine and your doctor decides to continue treatment, you must protect your skin from sunlight and must not use UV tanning booths (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 kidney function and especially your levels of sodium, potassium, calcium, blood sugar (glucose), and uric acid.

Elderly patients (65 years and older)

When treating elderly patients, possible limitations in kidney function should be taken into account (see section 3).

Other medicines and Hidroclorotiazida Aurovitas

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

• Lithium (a medicine used for mental health conditions), as its combination with hydrochlorothiazide may cause lithium overdose.

• Medicines to lower blood pressure or treat heart conditions (e.g., diuretics, ACE inhibitors such as ramipril, angiotensin II antagonists such as valsartan, digoxin, nitrates, and similar drugs).

• Medicines for mental health conditions such as depression, anxiety, schizophrenia (e.g., antidepressants, anxiolytics, antipsychotics, neuroleptics).

• Medicines to treat heart rhythm disorders (e.g., quinidine, 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 mainly used to treat high lipid levels in blood).

• Domperidone (to prevent nausea and vomiting).

• Medicines to treat malaria (e.g., halofantrine, lumefantrine).

• Medicines to treat allergic reactions (e.g., mizolastine, mequitazine).

• Antibiotics for treating 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 for erectile dysfunction.

• Medicines used in Parkinson’s disease (dopamine agonists, levodopa).

• Baclofen (to treat muscle stiffness occurring 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).

• Cyclosporine (used after organ transplantation, to treat autoimmune diseases or severe rheumatic or dermatological conditions).

Hidroclorotiazida Aurovitas with food and drink

Do not consume alcohol while taking this medicine, as it may cause orthostatic hypotension (a sudden drop in blood pressure causing dizziness when changing position, e.g., standing up).

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

In general, your doctor will recommend an alternative medicine instead of hydrochlorothiazide, as it is not recommended during pregnancy, except in rare cases where no other treatment can be used.

This medicine crosses 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 instructs you to do so.

Driving and using machines

Hydrochlorothiazide tablets may have a slight or moderate effect on the ability to drive and use machines.

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

This is particularly noticeable at the beginning of treatment, when the dose is increased, when medication is changed, or when taken together with alcohol.

Anti-doping test

Hydrochlorothiazide may produce a positive analytical result in an anti-doping test.

Hidroclorotiazida Aurovitas contains lactose

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

3. How to take Hydrochlorothiazide Aurovitas

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

Hydrochlorothiazide Aurovitas tablets are available in 3 strengths: 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 mg or 25 mg per day.

Elderly patients:

When treating elderly patients (65 years of age or older), possible impairment of renal function should be taken into account.

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 may be divided into equal doses.

Frequency of administration

This medicine has a diuretic effect (i.e., you will urinate more frequently). Because 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 periodic checks to ensure the treatment is having the expected effects. If you have any questions about the duration of treatment, consult your doctor or pharmacist.

If you take more Hydrochlorothiazide Aurovitas than you should

Contact your doctor or go immediately to the nearest hospital emergency department if you experience nausea, drowsiness, muscle cramps, cardiac arrhythmias (irregular heartbeat), low blood pressure (indicated by dizziness), confusion, or urinary problems.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 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, 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 instructed by your doctor. If you stop treatment, your blood pressure will not be controlled (see also “Duration of treatment”).

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 may cause adverse effects, although not everyone experiences them.

Effects requiring discontinuation of treatment

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

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

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

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Acute kidney failure (severely reduced urine output).

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

• Worsening of diabetes.
• Increased sensitivity to sunlight.
• Abdominal discomfort, constipation.
• Liver disorder, which may be accompanied by yellowing of the eyes and skin.
• Irregular heartbeat.
• Headache.
• Dizziness (vertigo).
• Sleep disorders.
• Feeling sad (depression).
• Tingling or numbness in hands or feet (paresthesia).
• Vision problems.
• Increased blood sugar levels.
• Sugar in urine.
• Increased calcium levels in blood (hypercalcemia).
• Low platelet count in 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 blood vessels, with symptoms such as rash, purplish-red skin spots, fever (necrotizing vasculitis).

• Severe skin reaction causing rash, redness of the skin, blisters on lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis).

• Allergic reaction (hypersensitivity reaction).

• Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion).

• Severe abdominal pain (pancreatitis).

• Bone marrow suppression leading to reduced production of red blood cells and/or abnormally low levels of white blood cells and platelets.

• Destruction of red blood cells causing paleness, fatigue, shortness of breath, dark urine (hemolytic anemia).

• Absence or low levels of white blood cells, which may cause fever, sore throat or mouth ulcers, more frequent infections (leukopenia or possible signs of agranulocytosis).

• Disturbance in acid-base balance causing confusion, fatigue, muscle twitching and spasms, rapid breathing (hypochloremic alkalosis).

Frequency not known (cannot be estimated from available data)

• Inadequate production of various blood cells by the bone marrow (myelosuppression).
• Markedly reduced urine production (possible signs of kidney problems).
• Serious skin disease causing rash, redness of the skin, blisters on lips, eyes or mouth, skin peeling, fever (erythema multiforme).
• Fever.
• Muscle spasms.
• Weakness (asthenia).
• Sudden decrease in distance vision (acute myopia), decreased vision or eye pain due to high intraocular 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 adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 Hydrochlorothiazide Aurovitas

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

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

This medicine does not require any special storage temperature conditions.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hydrochlorothiazide Aurovitas

• The active substance is hydrochlorothiazide. Each tablet contains 50 mg of hydrochlorothiazide.
• The other components are:

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

Appearance of the medicinal product and contents of the container

Uncoated tablets, white to off-white in colour, round-shaped, flat-faced with bevelled edges, marked with “HC 50” on one side and a score line on the other. The tablet can be divided into equal doses.

Hydrochlorothiazide Aurovitas tablets are available in blister packs and HDPE bottles.

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

HDPE bottle (for all strengths): 500 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area member states under the following names:

Germany HCT PUREN 50 mg Tabletten

Spain Hydrochlorothiazide Aurovitas 50 mg tablets

Italy Idroclorotiazide Aurobindo

Netherlands Hydrochloorthiazide Aurobindo 50 mg, tabletten

Poland Hydrochlorothiazide Aurovitas

Portugal Hydrochlorothiazide Generis

Czech Republic Hydrochlorothiazide Aurovitas

Date of the most recent review of this leaflet: March 2022

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)