HIGROTONA 50 mg tablets

Introduction

Patient Information: Summary of Product Characteristics

Higrotona 50 mg Tablets

Chlorthalidone

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 and other information

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

1. What is Higrotona and what is it used for

Higrotona belongs to a group of medicines called thiazide diuretics. It contains the active substance: chlorthalidone.

Thiazide diuretics help to reduce the amount of water in your body. They do this by increasing the production of urine, which in turn reduces blood pressure.

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

• Hypertension (high blood pressure) alone or in combination with other antihypertensive medications.
• Edema (excessive fluid retention in the tissues) due to kidney or liver disease.
• Nephrogenic 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).

of the kidney makes a person eliminate a large amount of urine).

2. What you need to know before you take Higrotona

Do not take Higrotona:

• If you are allergic to chlorthalidone or any of the other ingredients of this medicine (listed in section 6) or to any other medicine that stimulates urine production (ask your doctor or pharmacist what products contain these ingredients)

(including those listed in section 6) or any other medicine that stimulates urine production (ask your doctor or pharmacist what products contain these ingredients)

• If you do not urinate at all
• If you have severe kidney problems 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 suffering from gout
• If you are pregnant (see section "Pregnancy, breast-feeding 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 Higrotona.

• If you have kidney or liver disease
• If you have blood circulation 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.

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

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

or 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 medicine, also read the section on "Other medicines and Higrotona"
• If you experience a decrease in vision or eye pain, these 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 Higrotona. If this is not treated, it can lead to permanent vision loss. If you have ever been allergic to penicillin or sulfonamide, you may be more likely to experience this side 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.

Athletes are warned that this medicine contains a component that can produce a positive result in the doping test.

Children and adolescents

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

Other medicines and Higrotona

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. It may be necessary to change the dose or, in some cases, stop treatment with one of the medicines. This applies especially to:

• medicines that lower blood pressure or treat heart problems, such as:

or ACE inhibitors (e.g., lisinopril)

or beta blockers (e.g., propranolol hydrochloride)

or methyldopa

or vasodilators (e.g., bosentan)

or calcium channel blockers (e.g., amlodipine)

or guanethidine, diazoxide

or ketanserin

• adrenocorticotropic hormone (ACTH): used to treat a range of diseases, including ulcerative colitis, Crohn's disease, and rheumatoid arthritis

or 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
• medicines for infections (amphotericin)
• medicines for ulcers (carbenoxolone)
• medicines for certain mental disorders (lithium)
• anticholinergics, such as atropine sulfate or hysocine butylbromide: for abdominal or stomach spasms or cramps
• medicines used to lower cholesterol levels and prevent heart disease (cholestyramine)
• medicines for Parkinson's disease or viral infections (amantadine)
• medicines for gout (allopurinol)
• analgesics or anti-inflammatory medicines such as aspirin or indomethacin: used to relieve pain or rheumatism
• medicine for irregular heartbeat (digoxin)
• medicines for diabetes (insulin and other diabetes treatments such as chlorpropamide or glibenclamide. The dose may need to be adjusted)
• medicines for skin diseases or rheumatic conditions or after a transplant (ciclosporin)

-vitamin D and calcium salts used for replacement therapy

-anticoagulant medicines

Taking Higrotona with food, drink, and alcohol

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

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Do not take Higrotona if you are pregnant or trying to become pregnant (see section "Do not take Higrotona"). Tell your doctor immediately if you become pregnant during treatment with Higrotona.

Breast-feeding

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

For safety reasons, it is recommended that you do not breast-feed while taking Higrotona.

Fertility

Higrotona is not recommended for use in women of childbearing potential who are not using contraception, unless the clinical situation of the woman requires treatment with chlorthalidone.

Driving and using machines

Higrotona is unlikely to affect your ability to drive or use machines. However, as with other medicines used to treat high blood pressure, Higrotona may cause dizziness or drowsiness in some people, especially at the start of treatment, when changing dose, or when consuming alcohol. If you experience dizziness or drowsiness, consult your doctor before performing these activities.

Higrotona contains sodium

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

3. How to take Higrotona

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

The doses must always be adjusted individually. It is recommended to take the medicine 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 other origin: It is not recommended that the administered dose be higher than 50 mg/day. If an adequate response is not obtained, positive inotropics 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 the decrease in blood pressure is insufficient, it is recommended to associate it with other antihypertensives (e.g., beta blockers, vasodilators, calcium antagonists, ACE inhibitors, reserpine), with which, in general, the dosage of each component can be kept low.
• Nephrogenic 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 a suitable dose based on the child's age and weight.

Use in elderly or patients with kidney problems

Your doctor may prescribe 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

Chlorthalidone poisoning can cause dizziness, nausea (feeling unwell),

drowsiness (excessive daytime sleepiness), hypovolemia (shock), hypotension (low blood pressure), and electrolyte disorders 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken

If you forget to take Higrotona

Do not take a double dose to make up for forgotten doses.

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

If you stop taking Higrotona

Signs of disease that can be expected when treatment with Higrotona is stopped

There are no known signs of disease.

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

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

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4. Possible side effects

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

If you experience any of the following reactions, do not take any more Higrotona tablets. Tell your doctor immediately, or go to the casualty department of your nearest hospital:

• Allergic reactions: skin rash, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing. (frequency not known)
• Sore throat, fever, or chills (signs of a blood disorder) (uncommon).
• Yellowing of the eyes or skin (jaundice) (uncommon: 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)

or

• Decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye [choroidal effusion] or acute angle-closure glaucoma or acute myopia) (frequency not known).

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

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

• low blood potassium levels (hypokalemia);
• high blood uric acid levels (hyperuricemia);
• increased blood cholesterol levels (hyperlipidemia).

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

• tingling sensation;
• low sodium levels (hyponatremia);
• low magnesium levels (hypomagnesemia);
• high blood sugar levels (hyperglycemia);
• loss of appetite;
• dizziness;

or low blood pressure (hypotension);

• vomiting;
• nausea;
• diarrhea;

or stomach pain;

• constipation;
• erectile dysfunction and loss of libido.

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

• stiffness or tingling sensation in the hands, feet, or lips (paresthesia);
• bruising or abnormal bleeding (signs of thrombocytopenia);
• decreased white blood cell count (leucopenia);
• low white blood cell count (agranulocytosis);
• increased eosinophil count in the blood (eosinophilia);
• joint pain (signs of gout);
• headache;
• visual disturbances;
• disruption of bile release from liver cells (intrahepatic cholestasis);

or irregular heartbeat (arrhythmias);

• sugar in the urine (glucosuria) (would appear in the urine analysis performed by your doctor or nurse);
• worsening of diabetes;
• high blood calcium levels (hypercalcemia);
• hives (urticaria);

• increased sensitivity of the skin to sunlight (photosensitivity reaction).

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

• fluid accumulation in the lungs (pulmonary edema);
• low blood chloride levels (hypochloremic alkalosis);
• inflammation of blood vessels (vasculitis);
• inflammation of the kidney tubules (interstitial nephritis).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Higrotona

Keep this medicine out of the sight and reach of children. Store in the original packaging to protect from moisture.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Higrotona

The active substance is chlorthalidone. Each tablet contains 50 mg of chlorthalidone.

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

Appearance of the product and packaging

Flat, round, pale yellow tablets with beveled edges, scored and marked with Z/A on one side. The tablet can be divided into equal doses.

Each pack contains 30 tablets, packaged in blisters.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4, Ireland

Manufacturer:CENEXI SAS

52, Rue Marcel et Jacques Gaucher,

94120 Fontenay-Sous-Bois, France

You can obtain further information on this medicine from the representative of the marketing authorisation holder in your country:

FERRER INTERNACIONAL, S.A.

Gran Vía Carlos III, 94

08028 – Barcelona, Spain

Date of last revision of this leaflet:November 2020

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