Label: Information for the User

Drinetablets

Hidroclorotiazida

Read this label carefully before starting totake this medication, as it contains important information for you.

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

Drine tablets is a medication that contains hydrochlorothiazide as active ingredient. Hydrochlorothiazide is a diuretic (medication that increases the elimination of urine) that belongs to the group of thiazides. Hydrochlorothiazide increases the amount of urine (diuretic) helping to reduce blood pressure (antihypertensive).

This medication is indicated for the treatment of the following diseases:

• arterial hypertension (high blood pressure)
• edema (excess fluid in the tissue under the skin) due to heart failure, renal and hepatic insufficiency; premenstrual and idiopathic edemas (of unknown cause)
• renal diabetes insipidus (disorder in which a defect in the small renal tubules makes a person eliminate a large amount of urine) when treatment with antidiuretic hormone is not indicated
• idiopathic hypercalciuria (high levels of calcium in urine) as a preventive treatment of urinary tract stones (stones in the urinary system).

Do not take Drine 50 mg tablets

• If you are allergic to hydrochlorothiazide or any of the other components of Drine 50 mg tablets.
• If you have any of the following conditions: anuria (absence of urine elimination)
• If you are pregnant.
• If you are breastfeeding, as it is excreted in breast milk.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Drine.

Be especially careful with Drine 50 mg tablets if you have any of the following conditions:

• If you have kidney problems,
• If you have liver problems,
• If you have electrolyte imbalances, such as high levels of calcium in the blood,
• If you have metabolic and endocrine disorders,
• If you have a systemic autoimmune disease called systemic lupus erythematosus,
• 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 Drine tablets,
• If you have vision problems or eye pain (such as acute transient myopia and acute angle-closure glaucoma,
• If you have allergies or asthma,
• • If you have had skin cancer or if you develop an unexpected skin lesion 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 sun exposure and UV rays while taking Drine,
  • 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 Drine, seek medical attention immediately.

Use of Drine 50 mg tablets with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

The following medications may interact with Drine 25 mg tablets when used at the same time:

• muscle relaxants (such as baclofen, tubocurarine),
• other antihypertensives
• cholestyramine and cholestipol resins (used to reduce cholesterol levels),
• vasopressors (such as adrenaline),
• amphotericin B (injectable antibiotic), carbenoxolone (used to treat mouth sores), corticosteroids, hormones (such as corticotropin, adrenaline), laxatives (help with bowel evacuation),
• lithium (antidepressant),
• calcium salts,
• digitalis (digoxin),
• antiarrhythmic medications (such as sotalol, amiodarone) or capable of inducing Torsades de Pointes (a type of arrhythmia) such as intravenous erythromycin, mizolastine,
• antipsychotic medications (such as haloperidol),
• carbamazepine (for epilepsy),
• tetracyclines (antibiotic),
• anticholinergic agents (such as atropine),
• medications used to treat gout (such as probenecid, allopurinol),
• diazoxide (medications used to treat hypoglycemia),
• vitamin D,
• ciclosporin (medication used in transplant patients),
• medications used to reduce potassium levels,
• amantadine (antiviral medication),
• cytotoxic agents (such as methotrexate, cyclophosphamide),
• medications used to treat diabetes,
• anti-inflammatory medications (salicylate derivatives, indomethacin),
• alcohol, sleep-inducing medications (such as barbiturates or narcotics).

Hydrochlorothiazide may interfere with analytical diagnosis in some tests, such as: bentiramide test (gastric test), or parathyroid function test, decrease yodine-bound protein concentrations, modify blood test results and urine test results.

Use of Drine with food, beverages

In combination with alcohol consumption, this medication may cause dizziness, vertigo, or headache.

Pregnancy and Lactation

Consult your doctor or pharmacist before using any medication.

You should inform your doctor if you are pregnant or suspect you are pregnant..Generally, your doctor will advise you to take another medication instead of Drine 50 mg, as Drine 50 mg is not recommended during pregnancy. This is because hydrochlorothiazide crosses the placenta and its use after the first trimester of pregnancy may cause potentially harmful effects on the fetus and neonate..

Hydrochlorothiazide is excreted in human milk, so it is not recommended for lactating mothers.

Driving and operating machinery

It is unlikely that hydrochlorothiazide will affect your ability to drive or operate machinery.

Drine 50 mg tabletscontain lactose.

If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

Use in athletes

Notify athletes that this medication contains a component that may result in a positive analytical result for doping control.

Follow exactly the administration instructions forDrinetablets indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Usual doses are:

• Treatment of high blood pressure (elevated blood pressure): Initially, a dose of12.5 to25 mg once a day, which may be increased to 50 mg/day in one or two doses.
• Treatment of edema (excess fluid in the tissue under the skin):25 to100 mg/day administered in one or two doses.
• Treatment of bloating and weight gain associated with premenstrual syndrome:25 to50 mg administered in one or two doses.
• Treatment of diabetic nephropathy:50 to100 mg/day.
• Treatment of hypercalciuria (elevated calcium levels in urine): 50 mg administered in one or two doses.

Tablets should be taken orally.

Tablets can be taken whole, broken, or crushed, with a little water or other non-alcoholic beverage.

The tablet can be divided into equal doses. To do this, place it on a hard surface, with the breaking line facing up, and press on both sides of the groove with your index fingers. Do not use sharp objects to break the tablets.

Use in children

Usual doses in children are:

• Treatment of high blood pressure (elevated blood pressure): From1 to2 mg/kg of weight (which may be increased to 3 mg/kg) once a day administered in one or two doses.
• Treatment of edema (excess fluid in the tissue under the skin): 2 mg/kg/day administered in two doses.

If you take moreDrinetablets than you should

If you have taken moreDrinethan you should, you may experience severe hypotension (drastic reduction in blood pressure), unconsciousness, nausea, drowsiness, thirst, muscle pain, difficulty walking, cardiac arrhythmias, reduced heart rate, and renal failure.

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 takeDrinetablets

Do not take a double dose to compensate for the missed doses.

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

Like all medications, Drine tablets may cause side effects, although not everyone will experience them.

These side effects include:

Metabolic and nutritional alterations: loss of appetite, sugar and/or uric acid in urine, increased blood sugar, cholesterol, and triglycerides, electrolyte imbalance (potassium, sodium, chloride, and calcium).

Skin alterations: photosensitivity reactions, urticaria, skin rash, salivary gland inflammation, allergic reactions.

Unknown frequency: skin and lip cancer (non-melanoma skin cancer).

Renal and urinary alterations: kidney inflammation, increased urine production, frequent urination.

Reproductive and mammary gland alterations: impotence.

Psychiatric alterations: agitation, depression, sleep disorders.

Ocular alterations: transient blurred vision, yellow vision of objects.Unknown frequency:decreased 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].

Vascular alterations: inflammation of blood vessels.

Respiratory alterations:pneumonia, fluid accumulation in the lung,and very rare frequency: acute respiratory distress (symptoms include severe respiratory difficulty, fever, weakness, and confusion).

Gastrointestinal alterations:pancreatitis, gastric irritation, diarrhea, constipation, loss of appetite, nausea, and vomiting, abdominal pain and cramps.

Hepatic and biliary alterations:yellow skin discoloration.

Nervous system alterations:loss of appetite, movement difficulties, dizziness, vertigo, headache, weakness, restlessness.

Auditory alterations:vertigo.

Cardiac alterations:low blood pressure, arrhythmias, allergic inflammation of the cardiac muscle, inflammation of blood vessels.

Musculoskeletal alterations:muscle spasms.

General alterations:fever.

Immune system alterations:allergy.

Blood alterations:low levels of red blood cells, white blood cells, and platelets in the blood.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Store in the outer packaging to protect it from light.

Keep out of the reach and sight of children.

Do not use Drine tablets after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Hidrosaluretil 50 mg tablets

• The active ingredient is hydrochlorothiazide. Each tablet contains 50 mg of hydrochlorothiazide.
• The other components are lactose, cornstarch, microcrystalline cellulose, magnesium stearate, and methylhydroxyethylcellulose.

Appearance of the product and content of the packaging

It is presented in the form of white, round, and scored tablets.

The content of the packaging is 20 tablets.

Holder of the marketing authorization

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, 10th floor

08908 L'Hospitalet de Llobregat - Barcelona (Spain)

Responsible for manufacturing

LABORATORIOS ALCALA FARMA S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Spain

Last review date of this leaflet: November 2021.

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