Clopamid Vp

Leaflet attached to the packaging: patient information

Clopamid VP, 20 mg, tablets

Clopamidum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Clopamid VP and what is it used for
• 2. Important information before taking Clopamid VP
• 3. How to take Clopamid VP
• 4. Possible side effects
• 5. How to store Clopamid VP
• 6. Package contents and other information

1. What is Clopamid VP and what is it used for

Clopamid VP is a diuretic medicine from the group of thiazide-like diuretics. By increasing the excretion of water from the body, it reduces swelling.
The diuretic effect of the medicine occurs about 2 hours after oral administration, reaches its maximum after 1-4 hours, and lasts for about 24 hours from the time of administration.
Clopamid VP is used to treat swelling in heart, kidney, and liver failure.

2. Important information before taking Clopamid VP

When not to take Clopamid VP

• if you are allergic to clopamide or any other ingredient of this medicine (listed in section 6) or to sulfonamides
• if you have severe kidney failure (creatinine clearance <30 ml min), acute glomerulonephritis, anuria< li>
• if you have severe liver failure, hepatic coma
• if you have persistent hypokalemia, hypercalcemia, or hyperuricemia, decreased blood volume, or hyponatremia
• if you have Addison's disease (adrenal insufficiency)
• if you have porphyria (disorders of heme synthesis)
• if you are pregnant or breastfeeding (see section on pregnancy and breastfeeding).

Warnings and precautions

Before starting treatment with Clopamid VP, discuss it with your doctor, pharmacist, or nurse:

• if you have liver or kidney function disorders
• if you are taking digitalis glycosides (see "Clopamid VP and other medicines")
• if you have gout (Clopamid VP may increase uric acid levels in the blood and worsen the disease, so your doctor will recommend additional blood tests)
• if you have diabetes (Clopamid VP may increase blood glucose levels, so you may need to adjust your antidiabetic medication)
• if you have high cholesterol or triglyceride levels in the blood
• if you have severe coronary or cerebral atherosclerosis
• if you have systemic lupus erythematosus
• if you are elderly (you are more prone to electrolyte disturbances and dehydration, so you should be cautious when taking Clopamid VP and follow your doctor's instructions carefully)
• if you experience vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased intraocular pressure - they can occur within a few hours to weeks after taking Clopamid VP. If left untreated, they can lead to permanent vision loss. Patients who have previously been allergic to sulfonamides or penicillin may be at increased risk of these side effects. Due to the possibility of increased sensitivity to sunlight, people taking Clopamid VP should avoid prolonged sun exposure.

Clopamid VP may cause water and electrolyte disorders. If you experience any of the following symptoms while taking Clopamid VP: muscle cramps, weakness, drowsiness, low blood pressure, rapid heartbeat, thirst, gastrointestinal symptoms, inform your doctor. These may be symptoms of water and electrolyte disorders.
While taking Clopamid VP, avoid a strict low-sodium diet. In the case of long-term therapy, it is recommended to consume potassium-rich foods (dried fruits, legumes, fruits, fish, low-fat cheeses).

Clopamid VP and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Particularly inform your doctor or pharmacist if you are taking:

• other medicines that may lower blood pressure, such as nifedipine, amlodipine, barbiturates, chlorpromazine, tricyclic antidepressants, e.g., amitriptyline
• lithium salts (used to treat mood disorders)
• digitalis glycosides (used to treat heart conditions) - your doctor will recommend periodic ECG monitoring and potassium level checks
• non-steroidal anti-inflammatory drugs, such as ibuprofen, indomethacin, acetylsalicylic acid
• anticoagulant medicines, such as acenocoumarol
• insulin (used to treat diabetes)
• medicines used to treat heart rhythm disorders, such as amiodarone, disopyramide, quinidine, sotalol
• calcium preparations
• laxatives
• corticosteroids.

Taking Clopamid VP with food, drink, and alcohol

Clopamid VP can be taken with or without food.
Avoid excessive alcohol consumption while taking Clopamid VP.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Clopamid VP is contraindicated during pregnancy and breastfeeding.

Driving and operating machinery

Do not drive vehicles or operate machinery during the initial period of taking Clopamid VP, as it may cause dizziness or excessive fatigue.

3. How to take Clopamid VP

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Recommended dose:
Adults:
The initial dose, depending on the severity of symptoms, is 20-40 mg per day, preferably in the morning, after a meal. If necessary, your doctor will increase the daily dose to 60 mg and gradually decrease it as the swelling subsides. The maintenance dose is 10-20 mg per day or every other day.
Elderly patients (over 65 years):
No dose adjustment is necessary.
Patients with liver and kidney function disorders:
The medicine should not be used in patients with severe kidney or liver failure.
Children and adolescents:
Due to the lack of appropriate studies, the use of this medicine is not recommended in this age group.
Take Clopamid VP regularly.

Taking more than the recommended dose of Clopamid VP

If you take more than the recommended dose of Clopamid VP, you may experience:
decreased blood pressure when changing position from sitting or lying down to standing or sitting up, dizziness, fainting, nausea, vomiting, dizziness, water and electrolyte disturbances (mainly hypokalemia).
In case of overdose, consult your doctor, who will provide appropriate treatment.

Missing a dose of Clopamid VP

If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Clopamid VP

Stopping treatment with Clopamid VP may worsen the condition for which it was prescribed (worsening of swelling). Therefore, treatment should only be stopped under medical supervision.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Clopamid VP can cause side effects, although not everybody gets them.

The frequency of the following side effects is unknown (cannot be estimated from available data).

• increased glucose levels, diabetes, exacerbation of latent diabetes
• hypokalemia, hypomagnesemia, hyponatremia, hypercalcemia, hyperuricemia
• increased cholesterol and triglyceride levels in the blood
• dizziness, headache, drowsiness
• fatigue
• palpitations
• nausea, vomiting, diarrhea, constipation, abdominal pain, dry mouth
• skin rash
• vision loss or eye pain due to increased intraocular pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye or acute angle-closure glaucoma).

Generally, in connection with the use of thiazide diuretics, changes in blood counts, including decreased platelet count and white blood cell count, allergic reactions (including pneumonitis, pulmonary edema, severe skin reactions), orthostatic hypotension, pancreatitis, intrahepatic cholestasis, allergic skin reactions, urticaria, increased sensitivity to sunlight, sexual function disorders, impotence, may be reported.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Clopamid VP

Store in the original packaging.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer need. This will help protect the environment.

6. Package contents and other information

What Clopamid VP contains

• The active substance is clopamide. One tablet contains 20 mg of clopamide.
• The other ingredients are: potato starch, microcrystalline cellulose, povidone, talc, magnesium stearate.

What Clopamid VP looks like and what the pack contains

Clopamid VP tablets are packaged in blisters of 20 tablets each, made of Al/PVC foil.
A single carton contains 1 blister with an information leaflet.

Marketing authorization holder:

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer:

ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-105 Rzeszów, Poland
Tel. (48 17) 865 51 00
Date of leaflet approval:May 2025