CLORTALIDONE GLENMARK 50 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Clortalidone Glenmark 12.5 mg Tablets

Clortalidone Glenmark 25 mg Tablets EFG

Clortalidone Glenmark 50 mg Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Clortalidone Glenmark and what is it used for
2. What you need to know before taking Clortalidone Glenmark
3. How to take Clortalidone Glenmark
4. Possible side effects
5. Storage of Clortalidone Glenmark
6. Package contents and additional information

1. What is Clortalidone Glenmark and what is it used for

Clortalidone belongs to a group of medications called "diuretics", which help reduce the amount of water in the body. To do this, they increase the amount of water eliminated in the form of urine. They are sometimes called "water pills".

Clortalidone is used in adults to:

• Treat high blood pressure (hypertension)
• Treat heart failure
• Help reduce fluid retention in the liver or kidney
• Treat "nephrogenic diabetes insipidus"

2. What you need to know before taking Clortalidone Glenmark

Do not take clortalidone:

• if you are allergic to clortalidone, other thiazides, and sulfonamide derivatives (caution in patients with bronchial asthma) or to any of the other components of this medication (listed in section 6)
• if you do not produce urine (or produce less than 100 ml/24 h)
• if you have severe kidney problems (with greatly reduced or absent urine production; creatinine clearance less than 30 ml/min and/or serum creatinine greater than 1.8 mg/100 ml)
• if you have severe liver problems with altered consciousness (precoma and hepatic coma)
• if you have high levels of calcium in the blood (hypercalcemia)
• if you have very low levels of sodium in the blood (hyponatremia)
• if you have low levels of potassium in the blood (hypokalemia) or if you have an increased loss of potassium (e.g., due to vomiting or diarrhea)
• if you have high levels of uric acid in the blood
• if you have hypertension during pregnancy (see section "Pregnancy, breastfeeding, and fertility")

Warnings and Precautions

Consult your doctor or pharmacist before starting to take clortalidone:

• if you have a kidney or liver disorder
• if you suffer from diabetes mellitus(high blood sugar levels) or gout
• if you have high cholesterol levels
• if you follow a low-salt diet
• if you experience vision loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye or increased pressure in your eye and may occur within hours to weeks after taking Clortalidone. If left untreated, it can lead to permanent vision loss. If you have had an allergy to penicillin or sulfonamides in the past, you may be at higher risk of developing this disease.
• if you suffer from heart failure (cardiac failure)
• if you have a history of allergy or bronchial asthma

During treatment with clortalidone

• your doctor should perform periodic blood tests to measure potassium, sodium, calcium, creatinine, urea, blood fats (cholesterol and triglycerides), uric acid, and blood sugar
• you should drink enough water to avoid dehydration and eat potassium-rich foods (e.g., bananas, vegetables, nuts)
• regular medical check-ups are required in patients treated for high blood pressure (hypertension)

Clortalidone treatment should be discontinued, after consulting your doctor:

• if you have untreatable electrolyte disturbances (especially lack of potassium and sodium in the blood)
• if you have hypersensitivity reactions (allergies)
• if you experience severe gastrointestinal discomfort
• if you experience central nervous system disorders
• if you experience pancreatic inflammation (pancreatitis)
• if you experience changes in your blood count: decreased number of red or white blood cells or platelets (anemia, leucopenia, thrombocytopenia)
• if you experience acute inflammation of the gallbladder (cholecystitis)
• if you experience blood vessel inflammation (vasculitis)
• if your myopia is worsening
• if you have severe kidney problems (serum creatinine concentration greater than 1.8 mg/100 ml or creatinine clearance less than 30 ml/min)

Children and Adolescents

Since therapeutic experience is insufficient, clortalidone should not be used in children.

Clortalidone Glenmark and Doping Tests

Taking clortalidone may result in positive doping test results.

Other Medications and Clortalidone Glenmark

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, especially:

• medications for mental disorders, such as lithium, phenothiazines (e.g., chlorpromazine, ciamemazine, levomepromazine, thioridazine, trifluoperazine), benzamides (e.g., amisulpride, sulpiride, sultopride, tiapride), butyrophenones (e.g., droperidol, haloperidol)
• bepridil (for hypertension and chest pain)
• cisapride (for stomach acid)
• difemanil (for stomach ulcers and hyperacidity)
• certain antimicrobial agents (e.g., intravenous erythromycin, halofantrine, pentamidine, esparfloxacino, moxifloxacino, vincamine intravenously)
• certain antihistamines, such as mizolastine
• medications for pain and rheumatic diseases, such as indomethacin, acetylsalicylic acid (aspirin), COX-2 inhibitors, salicylates
• medications for hypertension or heart problems, such as
  • antiarrhythmics (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol)
  • ACE inhibitors (e.g., captopril or enalapril)
  • beta blockers (e.g., propranolol), diazoxide
  • methyldopa
  • vasodilators (e.g., bosentan)
  • calcium antagonists (e.g., amlodipine)
  • guanethidine
  • potassium-losing diuretics (e.g., furosemide)
  • cardiac glycosides (e.g., digoxin)

• corticosteroids, such as prednisolone or betamethasone, to treat allergic and inflammatory diseases and immune reactions
• adrenocorticotropic hormone (ACTH): used to treat various conditions, such as ulcerative colitis (a form of inflammatory bowel disease), Crohn's disease (a form of chronic inflammatory bowel disease), and rheumatoid arthritis.
• carbenoxolone (for ulcers)
• penicillin G (an antibiotic)
• certain laxatives
• amphotericin B (for fungal infections)
• medications used to treat depression (tricyclic antidepressants)
• nitrates (for chest pain)
• barbiturates (help with sleep, relieve anxiety, muscle spasms, prevent convulsions)
• insulin and other oral treatments for diabetes (oral antidiabetics, such as sulfonylureas)
• certain medications (that affect the sympathetic nervous system) in nasal drops and eye drops or cough syrups
• certain muscle relaxants, such as tubocurarine
• certain medications for cancer treatment (e.g., cyclophosphamide, fluorouracil, methotrexate)
• cholestyramine, colestipol (medications to reduce blood lipid levels)
• calcium salts, vitamin D (for replacement therapy)
• allopurinol (for gout treatment)
• amantadine (for Parkinson's disease or viral infections)
• cyclosporine (for rheumatic diseases, skin conditions, or after a transplant)
• anticholinergics such as atropine, biperiden (for abdominal or stomach spasms or cramps)

Taking Clortalidone Glenmark with Alcohol

Do not drink alcohol while taking clortalidone, as it increases the effects of alcohol.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before taking this medication.

Clortalidone should not be used during pregnancy. Inform your doctor immediately if you become pregnant during treatment.

Clortalidone is excreted in breast milk. Therefore, do not take this medication during breastfeeding (or stop breastfeeding).

Driving and Using Machines

Your response ability may be affected to such an extent, even when clortalidone is used as intended, that your ability to actively participate in traffic, operate machines, or work without a secure grip may be impaired. This is especially true at the start of treatment, when increasing the dose, in combination with other blood pressure-lowering medications, when changing medication, and in combination with alcohol.

Clortalidone Contains Lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medication.

Clortalidone Contains Sodium

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

3. How to Take Clortalidone Glenmark

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

How and When to Take the Tablets

Swallow the tablets whole with a glass of water. Take the tablets in the morning with breakfast. If you take the tablets twice a day, take the second dose with dinner. Do not increase the dose until 2 or 3 weeks have passed. The tablet can be divided into equal doses.

The Recommended Dose is as Follows:

High Blood Pressure (Hypertension)

The recommended initial dose is 12.5 mg/day. Useful doses range from 12.5 mg to 50 mg per day. The maximum effect is usually achieved with 25 mg per day. The full effect of a specific dose is achieved within 3-4 weeks.

For Treating Heart Failure

The recommended initial dose is 12.5 mg to 100 mg per day. Use the lowest effective dose in maintenance treatment, usually 12.5 mg to 50 mg per day.

The dose should be kept as low as possible to minimize the risk of safety problems, such as severe hypotension, renal failure, or hypokalemia. Maximum dose: 200 mg of clortalidone per day, as higher doses do not increase the effect.

Fluid Retention in Liver or Kidney

The recommended initial dose is 12.5 mg to 100 mg per day. Use the lowest effective dose in maintenance treatment, usually 12.5 mg to 50 mg per day.

The dose should be kept as low as possible to minimize the risk of safety problems, such as severe hypotension, renal failure, or hypokalemia. Maximum dose: 200 mg of clortalidone per day, as higher doses do not increase the effect.

Nephrogenic Diabetes Insipidus

Initial dose: 25 mg of clortalidone per day.

The dose may be increased based on efficacy and tolerability. The usual maintenance dose is 50 mg per day. A higher dose should be used with caution. The maximum dose is 100 mg twice a day.

Elderly Patients (Over 65 Years) and Patients with Kidney Problems

The dose should be adjusted according to therapeutic requirements and tolerance

Patients with Liver Problems

In the case of patients with liver problems, the alteration should be taken into account when deciding the dose of clortalidone. In the case of severe liver problems, clortalidone should not be taken.

Use in Children

Since sufficient experience is not available, clortalidone should not be used in children under 18 years of age.

If You Take More Clortalidone Glenmark Than You Should

Inform your doctor or contact the nearest hospital immediately.

If you take too many tablets, the following symptoms may appear:

Dizziness and weakness, nausea, drowsiness, headaches, rapid heartbeat, circulatory disorders with low blood pressure, and heart problems and muscle cramps.

If you become dehydrated, the following may appear: thickening of the blood, cramps, drowsiness, lack of enthusiasm (lethargy), confused states, circulatory collapse, and acute kidney failure.

Due to lack of potassium, the following may also appear: fatigue, muscle weakness, abnormal sensations (e.g., tingling or feeling cold) in arms and legs, paralysis, apathy, gas, and constipation, or heart problems. Severe potassium loss can cause intestinal obstruction and even lead to coma.

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

If You Forget to Take Clortalidone Glenmark

Take the next dose when it is due. Do not take a double dose to make up for forgotten doses.

If You Stop Taking Clortalidone Glenmark

Do not stop treatment without consulting your doctor first.

If you have any further questions about the use of this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Very Common (May Affect More Than 1 in 10 People):

• decrease in potassium levels in the blood, especially at high doses
• increase in uric acid levels in the blood, which can cause gout attacks in sensitive patients
• increase in blood fat levels (cholesterol and triglycerides)

Common (May Affect Up to 1 in 10 People):

• decrease in sodium and magnesium levels in the blood
• increase in blood sugar levels and increased sugar excretion in the urine
• worsening of diabetes symptoms or appearance of diabetes symptoms
• increase in nitrogen-containing substances (urea, creatinine), especially at the start of treatment
• headaches
• dizziness and weakness
• low blood pressure
• circulatory disorders with low blood pressure when standing up from a lying position (orthostatic intolerance)
• palpitations
• loss of appetite
• dry mouth
• gastrointestinal discomfort
• nausea
• vomiting
• discomfort in the upper abdomen
• abdominal cramps
• constipation
• diarrhea
• allergic skin reactions such as skin redness (exanthema), hives, itching (pruritus)
• decrease in muscle tone (hypotonia) of skeletal muscles
• muscle cramps
• impotence

Rare (May Affect Up to 1 in 1,000 People):

• reduction in the number of platelets and white blood cells
• almost complete absence of certain white blood cells, with a tendency to infections and severe general symptoms
• increase in the number of certain white blood cells
• increase in calcium levels in the blood
• abnormal sensations (e.g., tingling and numbness) in arms and legs
• visual disturbances
• limited tear fluid production
• heart rhythm disorders
• restriction of bile flow in the liver or jaundice
• increased skin reactions to light exposure, e.g., skin redness
• allergic vascular inflammation
• increase in uric acid levels in the blood (gout)

Very Rare (May Affect Up to 1 in 10,000 People):

• disruption of acid-base balance in the blood
• fluid retention in the lungs caused by hypersensitivity
• breathing difficulties
• pancreatitis
• allergic kidney inflammation

Frequency Not Known (Cannot Be Estimated from Available Data):

• vision loss or eye pain due to high pressure

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Clortalidone Glenmark

Keep this medication out of sight and reach of children.

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

Aluminum/Aluminum Blister: This medication does not require special storage conditions.

White Opaque PVC/PVDC Blister: This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Clortalidone Glenmark

• The active ingredient is clortalidone:
  • Clortalidone 12.5 mg tablets: each tablet contains 12.5 mg of clortalidone.
  • Clortalidone 25 mg tablets: each tablet contains 25 mg of clortalidone.
  • Clortalidone 50 mg tablets: each tablet contains 50 mg of clortalidone.

• The other components are microcrystalline cellulose (E 460), lactose monohydrate, sodium carboxymethyl starch (Type A), povidone K30 (E 1201), colloidal anhydrous silica (E 551), magnesium stearate (E 470b), purified water.

Appearance of the Product and Container Content

Clortalidone Glenmark 12.5 mg tablets: white, round (diameter = 5.60 mm approx.), flat, uncoated, marked with "Y" on one side and "37" on the other side.

Clortalidone Glenmark 25 mg tablets EFG: white, round (diameter = 7.00 mm approx.), flat, uncoated, smooth on one side and marked with "Y" and "53" on either side of the notch on the other side.

Clortalidone Glenmark 50 mg tablets EFG: white, round (diameter = 8.30 mm approx.), flat, uncoated, smooth on one side and marked with "Y" and "55" on either side of the notch on the other side.

Clortalidone tablets are presented in:

• Aluminum/Aluminum blisters in cardboard boxes containing 20, 50, and 100 tablets (12.5 mg and 25 mg) and 20, 30, 50, and 100 tablets (50 mg).
• White opaque PVC/PVDC blisters in cardboard boxes containing 20, 50, and 100 tablets (12.5 mg and 25 mg) and 20, 30, 50, and 100 tablets (50 mg).

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

566 17 Vysoké Mýto

Czech Republic

You can request more information about this medication by contacting the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medication has been authorized in the Member States of the European Economic Area under the following names:

Germany Chlortalidon Glenmark 12.5 mg Tabletten, Chlortalidon Glenmark 25 mg Tabletten, Chlortalidon Glenmark 50 mg Tabletten

Spain Clortalidona Glenmark 12.5 mg tablets, Clortalidona Glenmark 25 mg tablets EFG, Clortalidona Glenmark 50 mg tablets EFG

Netherlands Chloortalidon Glenmark 12.5 mg tablets, Chloortalidon Glenmark 25 mg tablets, Chloortalidon Glenmark 50 mg tablets

Date of the Last Revision of this Prospectus:April 2024.

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