Leaflet: Information for the Patient

Higrotona 50 mg Tablets

Clortalidona

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Higrotona is and what it is used for

2. What you need to know before taking Higrotona

3. How to take Higrotona

4. Possible side effects

5. Storage of Higrotona

6. Contents of the pack and additional information

Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It contains an active substance: chlorothiazide.

Thiazide diuretics help to reduce the amount of water in your body. They do this by stimulating the production of urine, thus reducing blood pressure.

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

- High blood pressure (elevated blood pressure) alone or in combination with other anti-hypertensive medicines.

- Edema (excessive fluid retention in tissues) due to kidney or liver disease.

- Renal diabetes insipidus (a disorder in which a defect in the small tubes (tubules)

of the kidney causes a person to eliminate a large amount of urine).

Do not take Higrotona:

- If you are allergic to clortalidona or any of the other components of this medication

(listed in section 6) or another medication that stimulates urine production (ask your doctor or pharmacist what products contain these ingredients)

- If you do not urinate at all

- If you have a severe kidney problem or severe liver disease

- If your blood potassium or sodium levels are too low or your blood calcium level is too high

- If you have ever had gout or kidney stones or are currently experiencing gout

- If you are pregnant (see section"Pregnancy, breastfeeding and fertility")

- If you have Addison's disease (also known as primary adrenal insufficiency or hypoadrenalism): a rare disorder of the adrenal glands.

Affects the production of two essential hormones called cortisol and aldosterone

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Warnings and precautions

Consult your doctor or pharmacist before starting to take Higrotona.

- If you have a kidney disorder or gastric disease

- If you have circulatory problems or heart disease

- If you have diabetes

- If your blood potassium, sodium or magnesium levels are too low, or your blood calcium levels are too high.

Low potassium levels in the blood can cause muscle weakness, muscle spasms or abnormal heartbeats.

Low sodium levels in the blood can cause fatigue, confusion, muscle contractions, seizures or coma.

High calcium levels in the blood can cause loss of appetite, fatigue or muscle weakness

- If your blood cholesterol level is too high

- If your blood uric acid levels have increased

- If you are taking any other medication, also read the section on "Other medications and Higrotona"

• If you experience a decrease in vision or eye pain, it may be a symptom of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or an increase in eye pressure and can occur within a few hours to a week after taking Higrotona. If this is not treated, it can lead to permanent vision loss. If you have ever had an allergy to penicillin or sulfonamide, you may be at higher risk of this adverse effect.

It is recommended to exercise caution if you take Higrotona and are undergoing analytical tests, as it may alter the results of these tests.

It is warned to athletes that this medication contains a component that can establish a positive result in the antidoping test.

Children and adolescents

Higrotona may cause dizziness and affect concentration, especially at the beginning of treatment. Parents/caregivers must ensure that children/adolescents do not drive or work with machinery until these effects have disappeared.

Other medications and Higrotona

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication. It may be necessary to change the dose or, in some cases, interrupt treatment with one of the medications. This applies in particular to:

- Medications that lower blood pressure or treat heart problems such as:

o Inhibitors of the ECA (e.g. lisinopril)

o Beta blockers (e.g. propranolol hydrochloride)

o Metildopa

o Vasodilators (e.g. bosentan)

o Calcium channel blockers (e.g. amlodipine)

o Guanetidina, diazoxide

o Ketanserina

- Adrenocorticotropic hormone (ACTH): used to treat a variety of diseases of different types, including ulcerative colitis, Crohn's disease and rheumatoid arthritis

- Corticosteroids such as prednisolone or betamethasone: used to treat allergic and inflammatory diseases and immune reactions

- Cytotoxic agents such as cyclophosphamide or methotrexate: used to treat cancer

- Asthma treatments such as formoterol or salbutamol

- Medications to treat infections (amphotericin)

- Medications to treat ulcers (carbenoxolone)

- Medications to treat certain mental disorders (lithium)

- Anticholinergics, such as atropine sulfate or hioscine butylbromide: for spasms or abdominal or stomach cramps

- Medications used to reduce cholesterol levels and prevent heart disease (cholestyramine)

- Medications to treat Parkinson's disease or viral infections (amantadine)

- Medications to treat gout (allopurinol)

- Analgesics or anti-inflammatory medications such as aspirin or indomethacin: used to relieve pain or rheumatism

- Medication to treat irregular heart rhythm (digoxin)

- Medications to treat diabetes (insulin and other diabetes treatments such as clorpropamida or glibenclamide. The dose may need to be adjusted)

- Medications to treat skin diseases or rheumatic diseases or after a transplant (ciclosporina)

- Vitamin D and calcium salts used for replacement therapy

- Anticoagulants

Higrotona with food, drink and alcohol

Avoid alcohol. Alcohol can cause a severe drop in blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy, breastfeeding and fertility

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

Pregnancy

Do not take Higrotona if you are pregnant or are trying to become pregnant (see section"Pregnancy, breastfeeding and fertility"). Inform your doctor immediately if you become pregnant during treatment with Higrotona.

Breastfeeding

Do not take Higrotona if you are breastfeeding, the active substance in Higrotona passes into breast milk and could harm your baby.

For safety reasons, it is recommended that you do not breastfeed while taking Higrotona.

Fertility

It is not recommended to use Higrotona in fertile women who do not use contraceptive methods, unless the woman's clinical situation requires treatment with clortalidona.

Driving and operating machinery

It is unlikely that Higrotona will affect your ability to drive or operate machinery. However, like other medications used to treat high blood pressure, Higrotona may cause dizziness or drowsiness in some people, especially at the beginning of treatment, when changing doses or if consuming alcohol. If you experience dizziness or drowsiness, consult your doctor before performing these activities.

Higrotona contains Sodium

This medication contains less than 1mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

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

The doses must be adjusted individually at all times. It is recommended to take the medication in a single dose, in the morning with breakfast.

In prolonged treatments, the lowest dose that produces an optimal effect will be used, especially in elderly patients.

-Edema of another origin: The administered dose should not exceed 50 mg/day. If an adequate response is not obtained, positive inotropic agents or an angiotensin-converting enzyme inhibitor will be administered.

-Hypertension (adults): In mild hypertension, a dose of 25 mg per day or 50 mg three times a week is often sufficient. If necessary, the dose can be increased to 50 mg per day. If blood pressure reduction is insufficient, it is recommended to associate it with other antihypertensive agents (e.g. beta-blockers, vasodilators, calcium antagonists, ACE inhibitors, reserpine), with which, in general, the dosage of each component can be kept low.

- Diabetes insipidus (adults): Initial dose, 100 mg of Higrotona, twice a day. For maintenance dose, 50 mg per day is usually sufficient.

Use in children

Your doctor will choose an appropriate dose based on the child's age and weight.

Use in elderly or patients with kidney problems

Your doctor may indicate a lower dose, as your body may not be able to eliminate Higrotona at the usual rate.

If you take more Higrotona than you should

Clortalidone overdose may cause dizziness, nausea (feeling of discomfort), somnolence (excessive daytime sleepiness), hypovolemia (shock), hypotension (low blood pressure), and electrolyte disturbances associated with cardiac arrhythmias (irregular heartbeat) and muscle spasms.

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 Higrotona

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

If you forget to take a dose, take it as soon as possible, unless it is almost time to take the next one. Never take two doses at the same time.

If you interrupt the treatment with Higrotona

Signs of disease that can be foreseen when treatment with Higrotona is suspended

No known signs of disease.

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

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

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

If any of the following reactions occur, do not use any more Higrotona tablets. Inform your doctor immediately, or go to the nearest hospital emergency department:

• Allergic reactions: skin rash, swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing.(Unknown frequency)

• Sore throat, fever, or chills (signs of a blood disorder) (infrequent).

• Yellowing of the eyes or skin (jaundice) (infrequent: may affect up to 1 in 100 people).• Stomach pain associated with nausea, vomiting, or fever (signs of pancreatitis) (very rare:

may affect up to 1 in 10,000 people)

Inform your doctor as soon as possible if you experience any of the following side effects:

Very frequent (may affect more than 1 in 10 people):

• Low levels of potassium in the blood (hypokalemia);

• High levels of uric acid in the blood (hyperuricemia);

• High levels of cholesterol in the blood (hyperlipidemia).

Frequent (may affect up to 1 in 10 people):

• Tingling sensation;

• Low levels of sodium (hyponatremia);

• Low levels of magnesium (hypomagnesemia);

• High levels of sugar in the blood (hyperglycemia);

• Loss of appetite;

• Dizziness;

• Low blood pressure (hypotension);

• Vomiting;

• Nausea;

• Diarrhea;

• Stomach pain;

• Constipation;

• Erectile dysfunction and loss of libido (impotence).

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

• Tingling or numbness in the hands, feet, or lips (paresthesia);

• Hematomas or abnormal bleeding (signs of thrombocytopenia);

• Decreased white blood cell count (leukopenia);

• Low white blood cell count (agranulocytosis);

• Increased eosinophil count in the blood (eosinophilia);

• Joint pain (signs of gout);

• Headache;

• Visual disturbances;

• Alteration in the release of a digestive fluid from the liver cells called bile (intrahepatic cholestasis);

• Irregular heart rhythm (arrhythmias);

• Sugar in the urine (glucosuria) (would appear in the urine analysis that your doctor or nurse will perform);

• Worsening of diabetes;

• High levels of calcium in the blood (hypercalcemia);

• Hives (urticaria);

• Increased skin sensitivity to sunlight (photosensitivity reaction).

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

• Excess fluid in the lungs (pulmonary edema);

• Low levels of chloride in the blood (hypochloremic alkalosis);

• Inflammation of the blood vessels (vasculitis);

• Inflammation of the renal tubules of the kidney (interstitial nephritis).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:

Medicamentos de Uso Humano:https://www.notificaram.es. By reporting side 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. Store in the original packaging to protect it from moisture.

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

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

Composition of Higrotona

The active principle is clortalidona. Each tablet contains 50 mg of clortalidona.

The other components are cornstarch, anhydrous colloidal silica, magnesium stearate, microcrystalline cellulose, yellow iron oxide (E-172), sodium carboxymethylcellulose.

Appearance of the product and contents of the packaging

Flat, round, pale yellow tablets with beveled edges, scored, and

with the Z/A imprint on one of its faces. The tablet can be divided into equal doses.

Each package contains 30 tablets, packaged in a blister.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4, Ireland

Responsible for manufacturing:CENEXI SAS

52, Rue Marcel et Jacques Gaucher,

94120 Fontenay-Sous-Bois, France

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

FERRER INTERNACIONAL, S.A.

Gran Vía Carlos III, 94

08028 – Barcelona, Spain

Date of the last review of this leaflet:November 2020

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